FDA Adverse Event
Malfunction
Summary report: N
PTCA CATHETERS
MDR report key: 542494
·
Received July 22, 2004
Report
- Report Number
- 6000089-2004-00657
- Event Type
- Malfunction
- Date Received
- July 22, 2004
- Date of Event
- June 12, 2004
- Report Date
- June 23, 2004
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LOX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A PTCA TREATMENT PROCEDURE, THE MAVERICK MONORAIL BALLOON RUPTURED AT 4 ATMS ON THE INITIAL INFLATION. THE LESION BEING TREATED WAS A 90% STENOTIC LESION IN THE LAD CORONARY ARTERY. THE PHYSICIAN USED A ZEON INTRODUCER SHEATH FOR VASCULAR ACCESS AND A JLL GUIDEWIRE AND MEDTRONIC GUIDE CATHETER TO CROSS THE LESION. THE MAVERICK MONORAIL BALLOON WAS REMOVED AND REPLACED WITH A SMART 2.5/20 MM BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS 'GOOD'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PTCA CATHETERS | MAVERICK MONORAIL PTCA CATHETER | LOX | BOSTON SCIENTIFIC | MAV-MR 20/2.5 | 5979382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |