FDA Adverse Event
Malfunction
Summary report: N
MUSTANG
MDR report key: 20925184
·
Received December 13, 2024
Report
- Report Number
- 2124215-2024-78982
- Event Type
- Malfunction
- Date Received
- December 13, 2024
- Date of Event
- October 31, 2024
- Report Date
- December 13, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729794349
- PMA / PMN Number
- K103751
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B- PRO CODE (PRODUCT CODE): LIT. E1 - INITIAL REPORTER FACILITY NAME: (B)(6). G4 - PREMARKET / 510(K) #: K110122.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE MIDDLE OF THE BALLOON CATHETER SHAFT BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2409766 | MUSTANG | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | BOSTON SCIENTIFIC CORPORATION | H74939171040670 | 0030233872 | 08714729794349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown |