FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MONORAIL PTCA CATHETER
MDR report key: 660823
·
Received January 4, 2006
Report
- Report Number
- 2132562-2006-00004
- Event Type
- Malfunction
- Date Received
- January 4, 2006
- Date of Event
- December 5, 2005
- Report Date
- December 5, 2005
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PCI PROCEDURE, LESION CROSSING DIFFICULTIES AND A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS IN THE 1ST DIAGONAL BRANCH OF THE PROXIMAL LAD CORONARY ARTERY. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING A CYPHER STENT WITH THE QUANTUM MAVERICK MONORAIL BALLOON CATHETER. AFTER CROSSING THE STENT, THE BALLOON RUPTURED AT 12 ATMS ON THE SECOND INFLATION. THE NUMBER OF ATMS REACHED ON THE INITIAL INFLATION IS UNKNOWN. A 7F BRITETIP JL4 GUIDE CATHETER, A TRECK AND WHISPER GUIDE WIRE, A CYPHER STENT, AND AN EVEREST INFLATION DEVICE WERE ALSO USED IN THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM MAVERICK MONORAIL PTCA CATHETER | PTCA CATHETER | LOX | BOSTON SCIENTIFIC | 15MM X 2.0MM | 7989697 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |