Device brand name · Wire guide catheter

Synchro-14 Straight 200-35cm: medical device reports filed with FDA

194 reports name it, 2020–2026. Manufacturer given most often on reports: Stryker Neurovascular-Utah-Salt Lake City. Product code DQX.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

194
device reports naming the brand: 0% of all MAUDE reports · about 30 a year; 15
reports, 12 months to August 2026: 23 in the 12 months before; 86.6%
classified as malfunction: 57.4% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

194 medical device reports received by FDA name the brand "Synchro-14 Straight 200-35cm" (wire guide catheter); the manufacturer given most often on reports is Stryker Neurovascular-Utah-Salt Lake City; received from February 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

15 reports arrived in the 12 months to August 2026, down 35% from 23 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (86.6%) and injury (13.4%); across all wire, guide, catheter reports (product code DQX) death is recorded in 2.8% and malfunction in 57.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fracture (63.9%), peeled/delaminated (33%) and material too rigid or stiff (0.5%). The patient problems coded most often are foreign body in patient, cognitive changes and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury13.4%26

Malfunction86.6%168

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%194

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 33,838 reports carrying product code DQX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Fracturea broken bone	124	63.9%	7.8%
Peeled/delaminated	64	33%	7.1%
Material too rigid or stiff	1	0.5%	0.1%
Physical resistance/sticking	1	0.5%	1.3%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Foreign body in patientpart of a device left in the patient	8	4.1%
Cognitive changes	2	1%
Device embedded in tissue or plaque	2	1%
Deaththe patient died; cause not stated by this term	1	0.5%
Hemorrhage/blood loss/bleeding	1	0.5%
Infarction, cerebral	1	0.5%
Movement disorder	1	0.5%
Visual impairmentreduced vision	1	0.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Synchro-14 Straight 200-35cm	Product code DQX	All MAUDE reports
Reports	194	33,838	26,136,888
Share of that pool	—	0.6%	0%
Classified as death, per 1,000 reports	0	28	9
Classified as injury	13.4%	38.9%	36.2%
Classified as malfunction	86.6%	57.4%	62.3%
Filed by the manufacturer	100%	88.6%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code DQX

Brand	Reports	Latest 12 months	Classified as death
V-18 Control Wire	554	47	0.7%
Amplatz Super Stiff	658	50	4.7%
Hi-Torque Balance Middleweight Universal Guide Wire	479	0	1.3%
Starter guidewire	422	179	1.2%
Amplatz Super Stiff Guidewire	403	0	3%
Acs Hi-Torque Balance Middleweight Guide Wire	380	0	3.2%
Arrow Ra Cath Set 22 Ga X 1-3/8	346	0	0%
Radifocus Glidewire	330	25	2.1%
V-14 Controlwire	325	0	0.3%
Pt	322	13	4%
V-14? Control Wire?	305	25	0.3%
Acs Hi-Torque Balance Middleweight Guide Wire With Hydrocoat Hydrophilic Coating	304	0	1.3%
Guide Wires	374	0	1.6%
Runthrough Ns	259	0	1.9%
Hi-Torque Pilot Guide Wire	256	0	4.3%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Synchro-14 Straight 200-35cm reports

How many FDA reports name Synchro-14 Straight 200-35cm?

194 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.

What kinds of events are reported?

malfunction (86.6%) and injury (13.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (63.9%), peeled/delaminated (33%), material too rigid or stiff (0.5%) and physical resistance/sticking (0.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Synchro-14 Straight 200-35cm was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.