FDA Adverse Event
Malfunction
Summary report: N
QUANTUM MAVERICK MR BALLOON CATHETER
MDR report key: 1203336
·
Received October 15, 2008
Report
- Report Number
- 2134265-2008-03039
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Report Date
- March 17, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LOX
- PMA / PMN Number
- P860019/S167
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
COMMON DEVICE NAME: LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS. 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 AT AN UNSPECIFIED TIME A BALLOON BURST OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM MAVERICK MR BALLOON CATHETER | NIQ STENT, CORONARY, DRUG-ELUTING | LOX | BOSTON SCIENTIFIC CORPORATION | 12X3.0MM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |