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

Model Number	FD0427-05
Medical Device Problem Codes	Entrapment of Device (1212); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was entrapped on the guidewire.An 8fr wolf thrombectomy catheter and v-14 control wire were selected for use in a thrombectomy procedure.The patient presented with an occluded popliteal artery.Access was achieved via ipsilateral approach with a non-bsc sheath.The v-14 control wire was antegrade through the popliteal artery.There was a high anterior tibial takeoff which started at the tibial plateau.The wolf catheter was successfully advanced to the blood clot.The clot was ingested using the pin and push technique.Resistance was observed when the wolf catheter was moved into the distal popliteal.After the clot had been captured, the wolf catheter was attempted to be removed over the v-14 control wire.The wolf catheter became entrapped on the wire.Both the wolf catheter and v-14 were removed together from the patient.The procedure was completed with the original device.There were no patient complications.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15878389
• Report Number: 2124215-2022-48005
• Device Sequence Number: 5362321
• Product Code: QEW
• UDI-Device Identifier: 00850029546245
• UDI-Public: 00850029546245
• 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): 11/29/2022

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: 03/28/2023
• Device Model Number: FD0427-05
• Device Lot Number: 0000200003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown