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Device brand name · Catheter percutaneous
GORE Molding & Occlusion Balloon Catheter: medical device reports filed with FDA
165 reports name it, 2020–2026. Manufacturer given most often on reports: W L Gore & Associates. Product code DQY.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 30
- reports, 12 months to August 2026
- 34 in the 12 months before
- 4.8%
- classified as malfunction
- 74.7% across the product code
- 5.5%
- classified as death, as reported
- 9 reports · not verified by FDA
165 medical device reports received by FDA name the brand "GORE Molding & Occlusion Balloon Catheter" (catheter percutaneous); the manufacturer given most often on reports is W L Gore & Associates; received from August 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
30 reports arrived in the 12 months to August 2026, down 12% from 34 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 injury (89.7%), death (5.5%) and malfunction (4.8%); 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 patient device interaction problem (36.4%), insufficient device problem information (6.7%) and patient-device incompatibility (5.5%). The patient problems coded most often are vascular dissection, perforation of vessels and rupture. 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
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Patient device interaction problem | 60 | 36.4% | 0.2% |
| Insufficient device problem information | 11 | 6.7% | 0.9% |
| Patient-device incompatibilitythe device did not suit the patient | 9 | 5.5% | 0.1% |
| Improper or incorrect procedure or method | 6 | 3.6% | 0.4% |
| Device handling problem | 3 | 1.8% | 0.1% |
| Material rupture | 2 | 1.2% | 16.9% |
| Positioning failure | 2 | 1.2% | 0.1% |
| Unintended deflation | 2 | 1.2% | 0% |
| Activation, positioning or separation problem | 1 | 0.6% | 0.1% |
| Breakthe device broke | 1 | 0.6% | 9.2% |
| Burst container or vessel | 1 | 0.6% | 1.5% |
| Detachment of device or device componentpart of the device came off | 1 | 0.6% | 4.6% |
| Inflation problem | 1 | 0.6% | 1.3% |
| Malposition of device | 1 | 0.6% | 0.1% |
| Material puncture/hole | 1 | 0.6% | 0.6% |
| Unintended movement | 1 | 0.6% | 0.2% |
| Volume accuracy problem | 1 | 0.6% | 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) | Reports | Share |
|---|---|---|
| Vascular dissection | 62 | 37.6% |
| Perforation of vessels | 30 | 18.2% |
| Rupturethe device burst | 18 | 10.9% |
| Embolism/embolus | 11 | 6.7% |
| Hemorrhage/blood loss/bleeding | 5 | 3% |
| Obstruction/occlusion | 5 | 3% |
| Aneurysm | 4 | 2.4% |
| Ruptured aneurysm | 4 | 2.4% |
| Clinical endoleak | 2 | 1.2% |
| Great vessel perforation | 2 | 1.2% |
| Ischemia | 2 | 1.2% |
| Muscle weakness/atrophy | 2 | 1.2% |
| Pseudoaneurysm | 2 | 1.2% |
| Renal impairmentreduced kidney function | 2 | 1.2% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE Molding & Occlusion Balloon Catheter | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 41,793 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 55 | 22 | 9 |
| Classified as injury | 89.7% | 22.7% | 36.2% |
| Classified as malfunction | 4.8% | 74.7% | 62.3% |
| Filed by the manufacturer | 100% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterling | 4,963 | 300 | 0.1% |
| Deflect | 1,021 | 247 | 0.1% |
| Guidezilla | 1,018 | 0 | 0% |
| Lantern Delivery Microcatheter | 887 | 19 | 0% |
| WATCHMAN FXD Curve Access System | 973 | 198 | 9.6% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Coyote? | 1,767 | 122 | 0.1% |
| Advance 35 Lp Low Profile Balloon Catheter | 572 | 15 | 0.5% |
| Conquest Pta Dilatation Catheter | 505 | 0 | 0.2% |
| WATCHMAN TruSeal Access System | 716 | 50 | 8% |
| Sterling Balloon Dilatation Catheter | 488 | 0 | 0.4% |
| React catheter | 516 | 41 | 18.4% |
| Conquest Pta Balloon Dilatation Catheter | 510 | 0 | 0.2% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Neuron Max 6f 088 Long Sheath | 389 | 0 | 0.5% |
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 GORE Molding & Occlusion Balloon Catheter reports
How many FDA reports name GORE Molding & Occlusion Balloon Catheter?
165 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 30 in the latest 12 months.
What kinds of events are reported?
injury (89.7%), death (5.5%) and malfunction (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (36.4%), insufficient device problem information (6.7%), patient-device incompatibility (5.5%), improper or incorrect procedure or method (3.6%) and device handling problem (1.8%). 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 GORE Molding & Occlusion Balloon Catheter 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.