XXL BALLOON DILATATION CATHETER
Report
- Report Number
- 2134265-2008-01512
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- April 29, 2008
- Report Date
- April 30, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LIT
- PMA / PMN Number
- K952063
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, BALLOON WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED AND A PERFORATION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE DESCENDING TRANSVERSE AORTIC ARTERY. ONE DAY PRIOR OT THIS PROCEDURE, ANOTHER MANUFACTURER'S STENT HAD BEEN DEPLOYED AND WAS FOUND TO HAVE MIGRATED. FOLLOWING INFLATIONS WITH SEVERAL BALLOONS, A 18MM X 2CM XXL BALLOON WAS ADVANCED. THE XXL BALLOON WAS INFLATED ONE TIME TO 4 ATMS. DURING WITHDRAWAL, THE XXL BALLOON "ACCORDIANED" THE UNKNOWN SHEATH, AND THE LEFT ILIAC/LEFT COMMON FEMORAL ARTERY WAS PERFORATED. THE PATIENT WAS TAKEN TO SURGERY FOR A FEMORAL EMBOLECTOMY AND REPAIR OF THE LEFT COMMON FEMORAL ARTERY. THE PATIENT WENT HOME THE DAY FOLLOWING SURGERY AND THE PATIENT STATUS WAS REPORTED AS 'FINE'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XXL BALLOON DILATATION CATHETER | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MULLINS INTRODUCER| AMPLATZ GUIDE WIRE| MEIER GUIDE WIRE| MAXI LD BALLOON |