MAUDE Adverse Event Report: DEVORO MEDICAL INC. SMARTCLAW?; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	FD0660-02
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
D4 - (root parent) udi identifier (udi) #: (b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: SMARTCLAW?
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): DEVORO MEDICAL INC.; 46724 lakeview blvd; fremont 94538
• Manufacturer (Section G): DEVORO MEDICAL, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22386240
• Report Number: 2124215-2025-43708
• Device Sequence Number: 20608328
• Product Code: QEW
• UDI-Device Identifier: 00850029546221
• UDI-Public: (01)00850029546221
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K241207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Model Number: FD0660-02
• Device Catalogue Number: FD0660-02
• Device Lot Number: 0000200077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown