Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Catheter percutaneous

Arrow Arterial Cath Set 20 Ga X 5cm: medical device reports filed with FDA

192 reports name it, 2023–2026. Manufacturer given most often on reports: Arrow International. Product code DQY.

192
device reports naming the brand
0% of all MAUDE reports · about 55 a year
74
reports, 12 months to August 2026
39 in the 12 months before
98.4%
classified as malfunction
74.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

192 medical device reports received by FDA name the brand "Arrow Arterial Cath Set 20 Ga X 5cm" (catheter percutaneous); the manufacturer given most often on reports is Arrow International; received from January 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

74 reports arrived in the 12 months to August 2026, up 90% from 39 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 (98.4%) and injury (1.6%); across all catheter, percutaneous reports (product code DQY) death is recorded in 2.2% and malfunction in 74.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are material twisted/bent (41.7%), deformation due to compressive stress (18.8%) and incorrect, inadequate or imprecise result or readings (13%). The patient problems coded most often are discomfort, hemorrhage/blood loss/bleeding and thrombosis/thrombus. 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

0917Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 3Feb 2023: 1Mar 2023: 4Apr 2023: 1May 2023: 5Jun 2023: 10Jul 2023: 2Aug 2023: 5Sep 2023: 10Oct 2023: 2Nov 2023: 3Dec 2023: 12024Jan 2024: 2Feb 2024: 4Mar 2024: 10Apr 2024: 1May 2024: 2Jun 2024: 1Jul 2024: 9Aug 2024: 3Sep 2024: 0Oct 2024: 3Nov 2024: 1Dec 2024: 22025Jan 2025: 1Feb 2025: 4Mar 2025: 0Apr 2025: 2May 2025: 1Jun 2025: 9Jul 2025: 7Aug 2025: 9Sep 2025: 17Oct 2025: 12Nov 2025: 4Dec 2025: 102026Jan 2026: 7Feb 2026: 5Mar 2026: 3Apr 2026: 2May 2026: 4Jun 2026: 1Jul 2026: 6Aug 2026: 3

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

038762023: 4720232024: 3820242025: 7620252026: 312026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.6%3
Malfunction98.4%189
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%192
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 41,793 reports carrying product code DQY. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Material twisted/bent8041.7%2.4%
Deformation due to compressive stress3618.8%2.3%
Incorrect, inadequate or imprecise result or readings2513%0.3%
Unable to obtain readings189.4%0.3%
Obstruction of flow178.9%0.6%
Device damaged prior to usethe device was damaged before use94.7%1.8%
Migrationthe device moved from where it was placed84.2%0.2%
No device output84.2%0%
Material separation73.6%4.1%
Complete blockage52.6%0.2%
Failure to obtain sample42.1%0.1%
Physical resistance/sticking42.1%2.9%
Unraveled material42.1%2.1%
Difficult to removethe device was hard to remove21%4.1%
Failure to advance21%2.6%
Incorrect measurementthe device measured wrongly21%0%
Material deformation21%5%
Dent in material10.5%0%
Disconnection10.5%0%
Failure to deliverthe device did not deliver the dose or item10.5%0%

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)ReportsShare
Discomfortdiscomfort115.7%
Hemorrhage/blood loss/bleeding31.6%
Thrombosis/thrombus31.6%
Foreign body in patientpart of a device left in the patient21%
Ecchymosis10.5%
Hypovolemic shock10.5%
Laceration(s)10.5%
Painpain, site not specified10.5%

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

In context

MeasureArrow Arterial Cath Set 20 Ga X 5cmProduct code DQYAll MAUDE reports
Reports19241,79326,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports0229
Classified as injury1.6%22.7%36.2%
Classified as malfunction98.4%74.7%62.3%
Filed by the manufacturer100%97.4%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 DQY

BrandReportsLatest 12 monthsClassified as death
Sterling4,9633000.1%
Deflect1,0212470.1%
Guidezilla1,01800%
Lantern Delivery Microcatheter887190%
WATCHMAN FXD Curve Access System9731989.6%
Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm1,4061700.1%
Coyote?1,7671220.1%
Advance 35 Lp Low Profile Balloon Catheter572150.5%
Conquest Pta Dilatation Catheter50500.2%
WATCHMAN TruSeal Access System716508%
Sterling Balloon Dilatation Catheter48800.4%
React catheter5164118.4%
Conquest Pta Balloon Dilatation Catheter51000.2%
Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm1,1101230.1%
Neuron Max 6f 088 Long Sheath38900.5%

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 Arrow Arterial Cath Set 20 Ga X 5cm reports

How many FDA reports name Arrow Arterial Cath Set 20 Ga X 5cm?

192 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 74 in the latest 12 months.

What kinds of events are reported?

malfunction (98.4%) and injury (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material twisted/bent (41.7%), deformation due to compressive stress (18.8%), incorrect, inadequate or imprecise result or readings (13%), unable to obtain readings (9.4%) and obstruction of flow (8.9%). 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 Arrow Arterial Cath Set 20 Ga X 5cm 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.