FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MR BALLOON CATHETER
MDR report key: 1470628
·
Received June 12, 2009
Report
- Report Number
- 2134265-2009-02766
- Event Type
- Malfunction
- Date Received
- June 12, 2009
- Date of Event
- May 14, 2009
- Report Date
- May 14, 2009
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P860019/S167
- 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 PERCUTANEOUS CORONARY ANGIOPLASTY (PTA) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATE TORTUOUS AND CALCIFIED UNKNOWN VESSEL. DURING THE 1ST INFLATION, IT WAS NOTED THAT A BALLOON RUPTURE OCCURRED WITHIN RATED BURST PRESSURE (RBP). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT'S 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, PERCUTANEO | LOX | BOSTON SCIENTIFIC | 12X2.5 MM | 11965938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |