MUSTANG
Report
- Report Number
- 2124215-2024-73375
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- November 6, 2024
- Report Date
- December 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729793441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K) #: K141521, K141597.
D2B - PRO CODE (PRODUCT CODE): FGE, LIT; G4 - PREMARKET / 510(K) #: K141521, K141597.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0 X 40, 75CM MUSTANG WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE REACHING THE RATED BURST PRESSURE (RB). THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED AXILLARY ARTERY. MOREOVER, THE BALLOON RUPTURED DURING SECOND INFLATION AT 18 ATMOSPHERES, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 12.0 X 40, 75CM MUSTANG WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE REACHING THE RATED BURST PRESSURE (RB). THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1999854 | MUSTANG | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171120470 | 0034354963 | 08714729793441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male |