FDA Adverse Event
Malfunction
Summary report: N
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
MDR report key: 17056211
·
Received June 2, 2023
Report
- Report Number
- 2124215-2023-28254
- Event Type
- Malfunction
- Date Received
- June 2, 2023
- Date of Event
- May 18, 2023
- Report Date
- June 2, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NWX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. ON AN UNSPECIFIED DATE, A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED. IN (B)(6) 2023, 50% IN-STENT RESTENOSIS (ISR) WAS NOTED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 15MMX3.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1487446 | WOLVERINE CORONARY CUTTING BALLOON MONORAIL | CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING | NWX | BOSTON SCIENTIFIC CORPORATION | 3852 | 0029539279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | STENT - XIENCE 3.5MM |