Devices › Catheter, percutaneous
Device brand name · Catheter percutaneous
Polarcath: medical device reports filed with FDA
164 reports name it, 2005–2013. Manufacturer given most often on reports: Boston Scientific - San Jose. Product code DQY.
- 164
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 34.1%
- classified as malfunction
- 74.7% across the product code
- 3.7%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 164 reports that name the brand "Polarcath" (catheter percutaneous), received between March 2005 and October 2013; the manufacturer given most often on reports is Boston Scientific - San Jose. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (60.4%), malfunction (34.1%) and death (3.7%); 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 other (for use when an appropriate device code cannot be identified) (23.8%), difficult to remove (4.9%) and material rupture (4.3%). The patient problems coded most often are intimal dissection, pain and reocclusion. 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
No report naming Polarcath was received in the five years to August 2026; the latest was received in October 2013.
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 |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 39 | 23.8% | 0.5% |
| Difficult to removethe device was hard to remove | 8 | 4.9% | 4.1% |
| Material rupture | 7 | 4.3% | 16.9% |
| Deflation problem | 6 | 3.7% | 2.7% |
| Inflation problem | 5 | 3% | 1.3% |
| Sticking | 5 | 3% | 0.5% |
| Tears, rips, holes in device, device material | 5 | 3% | 0.1% |
| Failure to advance | 4 | 2.4% | 2.6% |
| Balloon rupture | 3 | 1.8% | 1.4% |
| Balloon leak(s) | 2 | 1.2% | 0% |
| Balloon pinhole | 2 | 1.2% | 0% |
| Device, removal of (non-implant) | 2 | 1.2% | 0.4% |
| Hole in material | 2 | 1.2% | 0.5% |
| Kinkedthe tube or line kinked | 2 | 1.2% | 3.4% |
| Breakthe device broke | 1 | 0.6% | 9.2% |
| Connection problema connection problem | 1 | 0.6% | 0.3% |
| Crackthe device cracked | 1 | 0.6% | 1.8% |
| Defective devicethe device was defective | 1 | 0.6% | 0.2% |
| Detachment of device component | 1 | 0.6% | 2.2% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 1.8% |
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 |
|---|---|---|
| Intimal dissection | 49 | 29.9% |
| Painpain, site not specified | 26 | 15.9% |
| Reocclusion | 18 | 11% |
| Surgical procedure, additional | 16 | 9.8% |
| Stenosis | 6 | 3.7% |
| Occlusion | 5 | 3% |
| Hemorrhage/blood loss/bleeding | 3 | 1.8% |
| No patient involvement | 3 | 1.8% |
| Perforation of vessels | 3 | 1.8% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Pseudoaneurysm | 2 | 1.2% |
| Thrombosis | 2 | 1.2% |
| Vascular dissection | 2 | 1.2% |
| Blockage | 1 | 0.6% |
| Exsanguination | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Polarcath | Product code DQY | All MAUDE reports |
|---|---|---|---|
| Reports | 164 | 41,793 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 37 | 22 | 9 |
| Classified as injury | 60.4% | 22.7% | 36.2% |
| Classified as malfunction | 34.1% | 74.7% | 62.3% |
| Filed by the manufacturer | 97% | 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 Polarcath reports
How many FDA reports name Polarcath?
164 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (60.4%), malfunction (34.1%) and death (3.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (23.8%), difficult to remove (4.9%), material rupture (4.3%), deflation problem (3.7%) and inflation problem (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Polarcath 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.