FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MR BALLOON CATHETER
MDR report key: 1476260
·
Received June 19, 2009
Report
- Report Number
- 2134265-2009-02934
- Event Type
- Malfunction
- Date Received
- June 19, 2009
- Date of Event
- April 6, 2009
- Report Date
- May 22, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P030025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING UNPACKING A COMPROMISED POUCH WAS NOTICED. A QUANTUM MAV MON 12MM X 3.5MM HAD BEEN SELECTED. DURING UNPACKING, IT WAS NOTICED THAT "THE BALLOON WAS PROTRUDING THROUGH THE STERILE PACKAGE". THE DEVICE DID NOT COME INTO CONTACT WITH THE PT.
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 | 12X3.5 MM | 12169635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |