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

Model Number	FD0427-04
Medical Device Problem Codes	Mechanical Problem (1384); Defective Device (2588); Detachment of Device or Device Component (2907)
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
It was reported that the shaft detached.Left femoral access was obtained using a non-bsc 7fr sheath that went up and over the bifurcation and was parked in the right common femoral artery.After crossing from above and below, dr.Had a non-bsc 300cm.014 guidewire that extended from the non-bsc sheath, through the superficial femoral artery (sfa) lesion, down the anterior tibial artery and exiting a small sheath in the patients right foot, where a hemostat was clamped on the wire to ensure wire access would not be lost.A 7fr wolf arterial thrombectomy catheter was advanced to the target location.While pinning and pulling the device to capture the clot, resistance was noted.While finishing the sleeve pull, and removal of the inner catheter, the shaft snapped in half.The catheter was then removed from the patient.A new device, same model, was used to successfully complete the procedure.There were no patient complications.
Event or Problem Description
It was reported that the shaft detached.Left femoral access was obtained using a non-bsc 7fr sheath that went up and over the bifurcation, and was parked in the right common femoral artery.After crossing from above and below, dr.Had a non-bsc 300cm.014 guidewire that extended from the non-bsc sheath, through the superficial femoral artery (sfa) lesion, down the anterior tibial artery and exiting a small sheath in the patients right foot, where a hemostat was clamped on the wire to ensure wire access would not be lost.A 7fr wolf arterial thrombectomy catheter was advanced to the target location.While pinning and pulling the device to capture the clot, resistance was noted.While finishing the sleeve pull, and removal of the inner catheter, the shaft snapped in half.The catheter was then removed from the patient.A new device, same model, was used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis completed.The 7fr wolf device and two reload sleeves were returned for analysis.Visual inspection of the wolf device found that the devortex shaft on the returned primary sleeve was severed and the catheter nylon tip appeared folded into the catheter tip port.The reload sleeves were loaded into the catheter, and both met resistance when inserting the black puller knob through the catheter tip.A sleeve pull was performed, and both reload sleeves met resistance when the black flaps on the tip section of the sleeve were pulled through the catheter tip.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16772559
• Report Number: 2134265-2023-00030
• Device Sequence Number: 16956710
• 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,Followup
• Report Date (Section B): 06/29/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• 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