FDA Adverse Event
Injury
Summary report: N
POLARCATH
MDR report key: 1230028
·
Received November 12, 2008
Report
- Report Number
- 2953184-2008-00039
- Event Type
- Injury
- Date Received
- November 12, 2008
- Report Date
- October 28, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQY
- PMA / PMN Number
- K022061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ABOUT SIX MONTHS AFTER A CRYOPLASTY PROCEDURE ON THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES, THE PT RETURNED FOR FURTHER TREATMENT DUE TO RESTENOSIS. THE PT HAD ANOTHER ANGIOPLASTY AS THE DISEASE WAS MUCH MORE SEVERE THAN PRE-CRYOPLASTY. SIZE OF THE POLARCATH BALLOON CATHETERS USED 5MM, 4MM AND 3MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARCATH | DQY CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |