FDA Adverse Event
Malfunction
Summary report: N
VOYAGER NC CORONARY DILATATION CATHETER
MDR report key: 1872128
·
Received October 14, 2010
Report
- Report Number
- 2024168-2010-02146
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 19, 2010
- Report Date
- September 20, 2010
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DILATATION IN AN UNSPECIFIED VESSEL, THE VOYAGER NC BALLOON RUPTURED AT UNSPECIFIED ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOYAGER NC CORONARY DILATATION CATHETER | LOX | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8100761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |