FDA Adverse Event
Malfunction
Summary report: N
MAVERICK2 MONORAIL PTCA CATHETER
MDR report key: 1203340
·
Received October 15, 2008
Report
- Report Number
- 2134265-2008-03026
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Report Date
- January 4, 2007
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P860019/S179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE 2.0X15MM MAVERICK2 BALLOON CATHETER TO THE LESION AND INFLATED THE BALLOON AND IT RUPTURED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAVERICK2 MONORAIL PTCA CATHETER | LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC | MAVERICK2 15 / 2.0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |