FDA Adverse Event
Malfunction
Summary report: N
MAVERICK2 MONORAIL PTCA CATHETER
MDR report key: 1203644
·
Received October 16, 2008
Report
- Report Number
- 2134265-2008-03044
- Event Type
- Malfunction
- Date Received
- October 16, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P860019/S179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED DISTAL LEFT CIRCUMFLEX. A 2.0X15MM MAVERICK2 MONORAIL BALLOON WAS USED FOR PRE-DILATATION; HOWEVER, ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A MAVERICK2 2.25X15MM. THE PT STATUS IS GOOD WITH NO COMPLICATIONS REPORTED.
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 | 0011708872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |