Reported Reactions

Devices › Catheter, percutaneous

Device brand name · Pta balloon dilatation catheter

Conquest: medical device reports filed with FDA

358 reports name it, 2021–2026. Manufacturer given most often on reports: Bard Peripheral Vascular. Product code DQY.

358
device reports naming the brand
0% of all MAUDE reports · about 70 a year
70
reports, 12 months to August 2026
80 in the 12 months before
98.3%
classified as malfunction
74.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 358 reports that name the brand "Conquest" (pta balloon dilatation catheter), received between June 2021 and August 2026; the manufacturer given most often on reports is Bard Peripheral Vascular. Spellings of one product vary from report to report.

70 reports arrived in the 12 months to August 2026, down 12% from 80 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 (98.3%) and injury (1.7%); 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 rupture (66.8%), difficult to remove (16.5%) and deflation problem (14%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, stenosis and foreign body embolism. 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

0815Sep 2021: 2Oct 2021: 2Nov 2021: 4Dec 2021: 42022Jan 2022: 6Feb 2022: 2Mar 2022: 5Apr 2022: 3May 2022: 6Jun 2022: 5Jul 2022: 8Aug 2022: 5Sep 2022: 8Oct 2022: 3Nov 2022: 7Dec 2022: 32023Jan 2023: 2Feb 2023: 1Mar 2023: 2Apr 2023: 3May 2023: 2Jun 2023: 5Jul 2023: 1Aug 2023: 4Sep 2023: 8Oct 2023: 9Nov 2023: 9Dec 2023: 152024Jan 2024: 6Feb 2024: 12Mar 2024: 13Apr 2024: 8May 2024: 7Jun 2024: 6Jul 2024: 8Aug 2024: 7Sep 2024: 11Oct 2024: 6Nov 2024: 12Dec 2024: 62025Jan 2025: 8Feb 2025: 2Mar 2025: 8Apr 2025: 8May 2025: 6Jun 2025: 5Jul 2025: 6Aug 2025: 2Sep 2025: 10Oct 2025: 7Nov 2025: 4Dec 2025: 52026Jan 2026: 5Feb 2026: 3Mar 2026: 2Apr 2026: 8May 2026: 11Jun 2026: 6Jul 2026: 4Aug 2026: 5

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

0511022021: 1920212022: 6120222023: 6120232024: 10220242025: 7120252026: 442026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.7%6
Malfunction98.3%352
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.7%357
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.3%1

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 rupture23966.8%16.9%
Difficult to removethe device was hard to remove5916.5%4.1%
Deflation problem5014%2.7%
Unraveled material4011.2%2.1%
Material deformation339.2%5%
Peeled/delaminated287.8%1.3%
Material frayed277.5%1%
Detachment of device or device componentpart of the device came off236.4%4.6%
Breakthe device broke226.1%9.2%
Inflation problem205.6%1.3%
Leak/splashthe device leaked205.6%4.6%
Device-device incompatibility143.9%0.6%
Burst container or vessel123.4%1.5%
Difficult to open or remove packaging material82.2%0.1%
Difficult to insertthe device was hard to insert72%1.2%
Entrapment of device51.4%1.3%
Stretched41.1%0.5%
Failure to advance30.8%2.6%
Device dislodged or dislocated20.6%0.5%
Component misassembled10.3%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
Appropriate clinical signs, symptoms and conditions term/code not available20.6%
Stenosis20.6%
Foreign body embolism10.3%
Foreign body in patientpart of a device left in the patient10.3%
Hemoptysis10.3%
Perforation of vessels10.3%
Pulmonary edema10.3%
Vascular dissection10.3%

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

In context

MeasureConquestProduct code DQYAll MAUDE reports
Reports35841,79326,136,888
Share of that pool—0.9%0%
Classified as death, per 1,000 reports0229
Classified as injury1.7%22.7%36.2%
Classified as malfunction98.3%74.7%62.3%
Filed by the manufacturer99.7%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 Conquest reports

How many FDA reports name Conquest?

358 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 70 in the latest 12 months.

What kinds of events are reported?

malfunction (98.3%) and injury (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material rupture (66.8%), difficult to remove (16.5%), deflation problem (14%), unraveled material (11.2%) and material deformation (9.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Conquest 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.