Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Catheter percutaneous

Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm: medical device reports filed with FDA

1,406 reports name it, 2017–2026. Manufacturer given most often on reports: Arrow International. Product code DQY.

1,406
device reports naming the brand
0% of all MAUDE reports · about 148 a year
170
reports, 12 months to August 2026
234 in the 12 months before
98.4%
classified as malfunction
74.7% across the product code
0.1%
classified as death, as reported
2 reports · not verified by FDA

FDA's MAUDE database holds 1,406 reports that name the brand "Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm" (catheter percutaneous), received between January 2017 and August 2026; the manufacturer given most often on reports is Arrow International. Spellings of one product vary from report to report.

170 reports arrived in the 12 months to August 2026, down 27% from 234 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%), injury (1.4%) and death (0.1%); 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 (21.8%), deformation due to compressive stress (17.4%) and material deformation (13.7%). The patient problems coded most often are no patient involvement, hemorrhage/blood loss/bleeding and pain. 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

01835Sep 2021: 14Oct 2021: 6Nov 2021: 13Dec 2021: 82022Jan 2022: 15Feb 2022: 3Mar 2022: 11Apr 2022: 29May 2022: 12Jun 2022: 24Jul 2022: 15Aug 2022: 9Sep 2022: 10Oct 2022: 12Nov 2022: 12Dec 2022: 112023Jan 2023: 16Feb 2023: 10Mar 2023: 23Apr 2023: 12May 2023: 10Jun 2023: 13Jul 2023: 12Aug 2023: 22Sep 2023: 13Oct 2023: 11Nov 2023: 11Dec 2023: 202024Jan 2024: 9Feb 2024: 23Mar 2024: 8Apr 2024: 9May 2024: 6Jun 2024: 7Jul 2024: 10Aug 2024: 18Sep 2024: 9Oct 2024: 21Nov 2024: 22Dec 2024: 212025Jan 2025: 35Feb 2025: 20Mar 2025: 22Apr 2025: 23May 2025: 18Jun 2025: 11Jul 2025: 16Aug 2025: 16Sep 2025: 7Oct 2025: 18Nov 2025: 24Dec 2025: 92026Jan 2026: 23Feb 2026: 14Mar 2026: 13Apr 2026: 16May 2026: 8Jun 2026: 10Jul 2026: 16Aug 2026: 12

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

01102192017: 7120172018: 9020182019: 14520192020: 12020202021: 15020212022: 16320222023: 17320232024: 16320242025: 21920252026: 1122026

Event type and report source

Event type, as classified on the report

Death0.1%2
Injury1.4%20
Malfunction98.4%1,384
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,406
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/bent30721.8%2.4%
Deformation due to compressive stress24417.4%2.3%
Material deformation19213.7%5%
Leak/splashthe device leaked16111.5%4.6%
Fluid/blood leak987%2.1%
Physical resistance/sticking846%2.9%
Unraveled material624.4%2.1%
Material separation594.2%4.1%
Breakthe device broke453.2%9.2%
Crackthe device cracked433.1%1.8%
Device damaged prior to usethe device was damaged before use412.9%1.8%
Kinkedthe tube or line kinked402.8%3.4%
Difficult to advance261.8%1.8%
Obstruction of flow251.8%0.6%
Bent191.4%0.4%
Difficult to insertthe device was hard to insert181.3%1.2%
Difficult to removethe device was hard to remove141%4.1%
Failure to advance141%2.6%
Detachment of device or device componentpart of the device came off120.9%4.6%
Material split, cut or torn120.9%1.1%

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
No patient involvement392.8%
Hemorrhage/blood loss/bleeding60.4%
Painpain, site not specified60.4%
Device embedded in tissue or plaque50.4%
Foreign body in patientpart of a device left in the patient50.4%
Hypersensitivity/allergic reaction30.2%
Needle stick/puncture30.2%
Deaththe patient died; cause not stated by this term20.1%
Fever20.1%
Respiratory arrestbreathing stopped20.1%
Skin inflammation20.1%
Swellingswelling20.1%
Anaphylactoid / anaphylaxis10.1%
Discomfortdiscomfort10.1%
Hematomaa collection of blood under the skin or in tissue10.1%

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

In context

MeasureArrow Cvc Set 2-Lumen 7 Fr X 20 CmProduct code DQYAll MAUDE reports
Reports1,40641,79326,136,888
Share of that pool—3.4%0%
Classified as death, per 1,000 reports1229
Classified as injury1.4%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%
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%
WATCHMAN TruSteer? Access System4012609.2%

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 Cvc Set 2-Lumen 7 Fr X 20 Cm reports

How many FDA reports name Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm?

1,406 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 170 in the latest 12 months.

What kinds of events are reported?

malfunction (98.4%), injury (1.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material twisted/bent (21.8%), deformation due to compressive stress (17.4%), material deformation (13.7%), leak/splash (11.5%) and fluid/blood leak (7%). 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 Cvc Set 2-Lumen 7 Fr X 20 Cm 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.