FDA Adverse Event
Malfunction
Summary report: N
MAVERICK2 MONORAIL PTC CATHETER
MDR report key: 1033552
·
Received April 24, 2008
Report
- Report Number
- 2134265-2008-01193
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 3, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- PMA / PMN Number
- P860019/S179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), A BALLOON RUPTURED. THE 99% STENOSED LESION WAS SEVERELY CALCIFIED AND MODERATELY TORTUOUS IN THE DISTAL RIGHT CORONARY ARTERY. FOLLOWING THE GUIDEWIRE CROSSING THE LESION, A MAVERICK2 1.5MM BALLOON WAS DILATED. ON THE FIRST INFLATION, A 2.5X20MM MAVERICK2 MONORAIL BALLOON WAS INFLATED FOR ABOUT 10 SECONDS AND RUPTURED AT 10 ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE BALLOON WAS VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS IS LISTED AS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAVERICK2 MONORAIL PTC CATHETER | LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC | MAVERICK2 20 / 2.5 | 11026776 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |