FDA Adverse Event
Malfunction
Summary report: N
VOYAGER RX CORONARY DILATATION CATHETER
MDR report key: 1082765
·
Received July 24, 2008
Report
- Report Number
- 2024168-2008-00603
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 24, 2008
- Report Date
- June 24, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- LOX
- PMA / PMN Number
- P810046
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- 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 VOYAGER BALLOON RUPTURED AT 12 ATM DURING THE FIRST INFLATION. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOYAGER RX CORONARY DILATATION CATHETER | LOX | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8042141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |