FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MR BALLOON CATHETER
MDR report key: 1480702
·
Received July 22, 2009
Report
- Report Number
- 2134265-2009-03458
- Event Type
- Malfunction
- Date Received
- July 22, 2009
- Date of Event
- June 22, 2009
- Report Date
- June 22, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P860019/S179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (6). (B) (4).
Description of Event or Problem · 1
SAME CASE AS MFR REPORT #2134265-2009-03454. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE THE GAUGE FAILED. THE 90% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A QUANTUM MAV MON 8MM X 2.5MM BALLOON CATHETER WAS INFLATED ONCE WITH AN ENCORE26 INFLATION DEVICE. ON THE 2ND ATTEMPT, THE PHYSICIAN INFLATED THE BALLOON TO 12 ATMS. THE GAUGE OF THE INFLATION DEVICE "SUDDENLY" WENT DOWN; HOWEVER, THE BALLOON "APPEARED TO INFLATE." THE PROCEDURE WAS COMPLETED WITH ANOTHER OF BOTH THE INFLATION DEVICE AND BALLOON CATHETER. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM MAVERICK MR BALLOON CATHETER | LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC | 8X2.5 MM | 12398507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |