FDA Adverse Event
Malfunction
Summary report: N
WOLF THROMBECTOMY SHEATH
MDR report key: 17646476
·
Received August 29, 2023
Report
- Report Number
- 2124215-2023-45221
- Event Type
- Malfunction
- Date Received
- August 29, 2023
- Date of Event
- July 31, 2023
- Report Date
- August 29, 2023
- Manufacturer
- DEVORO MEDICAL, INC
- Product Code
- QEW
- UDI-DI
- 00850029546153
- PMA / PMN Number
- K210911
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SHEATH WAS DIFFICULT TO REMOVE. A WOLF THROMBECTOMY SHEATH WAS USED IN A THROMBECTOMY PROCEDURE. DURING SHEATH REMOVAL, THERE WAS A FAIR AMOUNT OF RESISTANCE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729863 | WOLF THROMBECTOMY SHEATH | PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION | QEW | DEVORO MEDICAL, INC | 0000247769 | 00850029546153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |