MAUDE Adverse Event Report: DEVORO MEDICAL, INC WOLF THROMBECTOMY SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	FD0427-04
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable upon analysis completed on 22may2023.It was reported that the catheter had kinked.A 7fr wolf arterial thrombectomy catheter was selected for use.Left femoral access was obtained and a guide sheath was inserted over the bifurcation into the right common femoral artery.A 7fr wolf arterial thrombectomy catheter was advanced.Upon ingesting the clot using a pin and pull method, resistance was observed.After the sleeve had captured the clot, the inner catheter was attempted to be removed.However, during removal the shaft snapped in half.The entire device was successfully removed.A second device, same model, was selected for use.The remaining clot was successfully removed using this catheter.Upon removal, it was observed the catheter was kinked.The procedure was completed.There were no patient complications.However, device analysis revealed a fracture at the kinked area on the catheter.
Additional Manufacturer Narrative
Device eval by mfr: the 7fr wolf device and two reload sleeves were returned for analysis.Visual inspection of the wolf device found that the catheter was kinked and breaking at 104cm from the strain relief.The sleeve shaft also showed kinking at 124cm from the black pull knob.The reload sleeves were unused.The catheter started breaking at the kink point during the product analysis.The reported event of kinking of the catheter was confirmed, and additionally it was found that the catheter was breaking at the kink.

• Brand Name: WOLF THROMBECTOMY SYSTEM
• 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.; 46724 lakeview blvd; fremont CA 94538
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17099415
• Report Number: 2134265-2023-00058
• Device Sequence Number: 20755810
• Product Code: QEW
• UDI-Device Identifier: 00850029546238
• UDI-Public: 00850029546238
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210530
• 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
• Report Date (Section B): 06/09/2023

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: 06/28/2023
• Device Model Number: FD0427-04
• Device Lot Number: 0000200012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown