FDA Adverse Event
Malfunction
Summary report: N
TYSHAK MINI®
MDR report key: 18011203
·
Received October 26, 2023
Report
- Report Number
- 18011203
- Event Type
- Malfunction
- Date Received
- October 26, 2023
- Date of Event
- June 5, 2023
- Report Date
- September 29, 2023
- Manufacturer
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Product Code
- DQY
- 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
SLEEVE WILL NOT SLIDE OFF BALLOON. WILL NOT ALLOW BALLOON TO ENTER THROUGH INTRODUCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2000708 | TYSHAK MINI® | CATHETER, PERCUTANEOUS | DQY | B BRAUN INTERVENTIONAL SYSTEMS, INC | 611991 | TYM-2532-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 270 DA | Female |