FDA Adverse Event
Injury
Summary report: N
TYSHAK II VALVE BALLOON CATHETER
MDR report key: 19449193
·
Received May 31, 2024
Report
- Report Number
- MW5155684
- Event Type
- Injury
- Date Received
- May 31, 2024
- Date of Event
- May 24, 2024
- Report Date
- May 29, 2024
- Manufacturer
- B. BRAUN INTERVENTIONAL SYSTEMS INC.
- Product Code
- DQY
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING A VALVULOPLASTY, THE BALLOON RUPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149836 | TYSHAK II VALVE BALLOON CATHETER | CATHETER, PERCUTANEOUS | DQY | B. BRAUN INTERVENTIONAL SYSTEMS INC. | PDC528 | TT-19526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Hospitalization |