FDA Adverse Event
Malfunction
Summary report: N
VOYAGER RX CORONARY DILATION CATHETER
MDR report key: 1203131
·
Received October 9, 2008
Report
- Report Number
- 2024168-2008-00911
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 10, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- P810046
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE BALLOON RUPTURED AT 6 ATM PRESSURE. A SECOND VOYAGER WAS USED TO COMPLETE THE PROCEDURE WITH SUCCESS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOYAGER RX CORONARY DILATION CATHETER | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8041141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | GUIDE WIRE: BMW| STENT: ML VISION| INFLATION: BOSTON| SHEATH: MERIT |