WANDA PTA BALLOON DILATATION CATHETER
Report
- Report Number
- 2134265-2009-06849
- Event Type
- Malfunction
- Date Received
- December 7, 2009
- Report Date
- November 17, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LIT
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
ADD'L MODEL# 135CM. THE DEVICE HAS BEEN DISPOSED AND IS NOT EXPECTED FOR RETURN; THEREFORE, 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. (B)(4).
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY (LCI). THE WANDA PTA BALLOON DILATATION CATHETER WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION. UPON THE FIRST INFLATION TO 14ATMS, A BALLOON RUPTURE OCCURRED. THE INFLATION DURATION IS UNK. THE BALLOON WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS OR INJURIES REPORTED. THE PT STATUS IS LISTED AS 'GOOD'. THE PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WANDA PTA BALLOON DILATATION CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC | 7.0-20MM | 12374115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INTRODUCER SHEATH| 6F TERUMO GUIDEWIRE| 0.035 INCH TERUMO |