PTCA CATHTERS
Report
- Report Number
- 6000093-2006-02381
- Event Type
- Malfunction
- Date Received
- November 17, 2006
- Report Date
- October 19, 2006
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- LOX
- PMA / PMN Number
- P860019 S201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
RETURNED PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS REC'D IN GOOD CONDITION WITH NO DAMAGE OBSERVED. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL REVEALED A TEAR IN THE BALLOON WALL LOCATED 6 MILLIMETERS PROXIMALLY FROM THE DISTAL TIP. EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE MANUFACTURING RECORDS FOR TOP ASSEMLY BATCH 8925607 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED.
IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED IS UNKNOWN. ACCORDING TO THE CUSTOMER, "BALLOON RUPTURE ON INITIAL INFLATION AT 8 ATMS." THE PT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PTCA CATHTERS | LOX-CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO | LOX | BOSTON SCIENTIFIC CORP. | MAVERICK2 | 8925607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |