FDA Adverse Event
Malfunction
Summary report: N
TIGERTRIEVER 13 REVASCULARIZATION DEVICE
MDR report key: 20832147
·
Received December 3, 2024
Report
- Report Number
- 20832147
- Event Type
- Malfunction
- Date Received
- December 3, 2024
- Date of Event
- September 30, 2024
- Report Date
- November 15, 2024
- Manufacturer
- RAPID MEDICAL, INC.
- Product Code
- NRY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
TIGERTRIEVER 13 STENT-RETRIEVER DEVICE DISTAL END FRACTURED AND DETACHED DURING EMERGENT STROKE THROMBECTOMY PROCEDURE, AND COULD NOT BE RECAPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2266691 | TIGERTRIEVER 13 REVASCULARIZATION DEVICE | CATHETER, THROMBUS RETRIEVER | NRY | RAPID MEDICAL, INC. | TRPP7144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |