FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MR BALLOON CATHETER
MDR report key: 1140690
·
Received August 28, 2008
Report
- Report Number
- 2134265-2008-02479
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 4, 2008
- 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
Description of Event or Problem · 1
SAME PATIENT AS 2134265-2008-02480. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTIONAL PROCEDURE, A BALLOON RUPTURED OCCURRED. THE LESION WAS LOCATED IN THE CALCIFIED, MODERATELY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS ATTEMPTING TO TREAT A TAXUS IN-STENT RESTENOSIS WITH A 4.5X8MM QUANTUM MAVERICK BALLOON, BUT THE BALLOON RUPTURED AT 10 ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM MAVERICK MR BALLOON CATHETER | LOX CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC | 8X4.5MM | 11084347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |