FDA Adverse Event
Malfunction
Summary report: N
TYSHAK MINI
MDR report key: 21157423
·
Received January 15, 2025
Report
- Report Number
- 21157423
- Event Type
- Malfunction
- Date Received
- January 15, 2025
- Date of Event
- December 27, 2024
- Report Date
- January 12, 2025
- Manufacturer
- B. BRAUN INTERVENTIONAL SYSTEMS, INC
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DR. TRIED TO PASS BALLOON OVER .014 GRAND SLAM WIRE. BALLOON BECAME STUCK AND WAS UNABLE TO BE REMOVED FROM THE WIRE (OUTSIDE OF BODY). A THIRD PERSON SCRUBBED IN, AND WITH A LOT OF FORCE BALLOON WAS REMOVED FROM WIRE. A NEW BALLOON WAS OBTAINED AND PASSED SMOOTHLY OVER THE WIRE INTO THE BODY. NO PATIENT HARM OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 968638 | TYSHAK MINI | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | B. BRAUN INTERVENTIONAL SYSTEMS, INC | 611989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 DA | Female |