SMARTCLAW?
Report
- Report Number
- 2124215-2025-43708
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 5, 2025
- Report Date
- July 29, 2025
- Manufacturer
- DEVORO MEDICAL INC.
- Product Code
- QEW
- UDI-DI
- 00850029546221
- PMA / PMN Number
- K241207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4 - (ROOT PARENT) UDI IDENTIFIER (UDI) #: (B)(4).
D4 - (ROOT PARENT) UDI IDENTIFIER (UDI) #: (B)(4). DEVICE EVAL BY MFR: THE DEVICE WAS RECEIVED, AND ANALYSIS WAS COMPLETED. VISUAL INSPECTION OF THE RETURNED SMARTCLAW DEVICE SHOWED THE BASKET NOT FULLY EXPANDED AND IT APPEARED TO HAVE A WIRE STICKING OUT FROM THE DISTAL BOND. THE HANDLE WAS OPENED AND THE OUTER SHAFT WAS CUT IN ORDER TO BE ABLE TO EXPAND THE BASKET. ACTUATION OF THE DEVICE WAS NOT POSSIBLE DUE TO THE WIRE STICKING OUT OF THE DISTAL BOND. NO OTHER ABNORMALITIES WERE FOUND DURING ANALYSIS.
IT WAS REPORTED THAT THE BASKET DETACHED. A WOLF SMARTCLAW MECHANICAL THROMBECTOMY CATHETER WAS SELECTED FOR USE IN AN ILIOCAVAL THROMBECTOMY PROCEDURE. THE TARGET LOCATION WAS THE INFERIOR VENA CAVA (IVC). THE WOLF SMARTCLAW WAS ADVANCED INTO THE IVC CLOT AND INSIDE A PREVIOUSLY IMPLANTED NON-BSC STENT. THE WOLF SMARTCLAW BASKET WAS DEPLOYED AND AN INITIAL PASS WAS MADE THROUGH THE CLOT. AFTER REMOVAL FROM SHEATH, IT WAS OBSERVED THAT A WIRE IN THE BASKET HAD DETACHED. A NON-BSC WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
IT WAS REPORTED THAT THE BASKET DETACHED. A WOLF SMARTCLAW MECHANICAL THROMBECTOMY CATHETER WAS SELECTED FOR USE IN AN ILIOCAVAL THROMBECTOMY PROCEDURE. THE TARGET LOCATION WAS THE INFERIOR VENA CAVA (IVC). THE WOLF SMARTCLAW WAS ADVANCED INTO THE IVC CLOT AND INSIDE A PREVIOUSLY IMPLANTED NON-BSC STENT. THE WOLF SMARTCLAW BASKET WAS DEPLOYED AND AN INITIAL PASS WAS MADE THROUGH THE CLOT. AFTER REMOVAL FROM SHEATH, IT WAS OBSERVED THAT A WIRE IN THE BASKET HAD DETACHED. A NON-BSC WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12282 | SMARTCLAW? | PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION | QEW | DEVORO MEDICAL INC. | FD0660-02 | 0000200077 | 00850029546221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |