FDA Adverse Event
Malfunction
Summary report: N
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
MDR report key: 1203341
·
Received October 15, 2008
Report
- Report Number
- 2134265-2008-03029
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Report Date
- January 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- MAF
- PMA / PMN Number
- P040016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A 2.25X12MM LIBERTE BARE MONORAIL CORONARY BALLOON BURST OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM | MAF STENT, CORONARY | MAF | BOSTON SCIENTIFIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |