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

Lot Number	0000200071
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sleeve detached.A 12mm wolf venous thrombectomy catheter was selected for use is the distal femoral vein.The 12mm wolf venous catheter was successfully advanced through the wolf sheath.However, the funnel on the wolf venous catheter could not deploy as it was too large.The wolf venous catheter and sheath were successfully removed and exchanged for new devices.An 8mm wolf venous thrombectomy catheter was advanced to the target lesion and successfully used.As the thrombectomy procedure progressed into larger venous anatomy (proximal femoral artery), it was determined a larger wolf venous catheter was required.A 12mm wolf venous catheter was then advanced to the proximal femoral vein, however, it was observed that the catheter was too large as well.During removal of the wolf venous catheter into the wolf sheath, the 12mm funnel sleeve detached.The 12mm funnel wolf catheter, sleeve and wolf sheath were all able to be removed from the patient easily with no harm to the patient.
Event or Problem Description
It was reported that the sleeve detached.A 12mm wolf venous thrombectomy catheter was selected for use is the distal femoral vein.The 12mm wolf venous catheter was successfully advanced through the wolf sheath.However, the funnel on the wolf venous catheter could not deploy as it was too large.The wolf venous catheter and sheath were successfully removed and exchanged for new devices.An 8mm wolf venous thrombectomy catheter was advanced to the target lesion and successfully used.As the thrombectomy procedure progressed into larger venous anatomy (proximal femoral artery), it was determined a larger wolf venous catheter was required.A 12mm wolf venous catheter was then advanced to the proximal femoral vein, however, it was observed that the catheter was too large as well.During removal of the wolf venous catheter into the wolf sheath, the 12mm funnel sleeve detached.The 12mm funnel wolf catheter, sleeve and wolf sheath were all able to be removed from the patient easily with no harm to the patient.
Additional Manufacturer Narrative
Device eval by mfr: the catheter was returned within the sheath, and the funnel was deployed within the sleeve.The sleeve was able to be removed from the catheter, and the catheter was removed from the sheath for decontamination.The wolf catheter was examined for visual abnormalities.It was found that the sleeve was damaged and detached approximately 33cm between the distal end of the devortex shaft and the proximal end of the sleeve.It was also found that the marker band coating approximately 68cm from the strain relief was flaking off of the catheter.There were no visual abnormalities noted to the sheath.The wolf catheter was reloaded with a new sleeve and inserted into the returned sheath.The catheter funnel was able to be deployed out of the end of the sheath and a successful sleeve pull was performed.

• 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 ; 6512422111
• MDR Report Key: 17646310
• Report Number: 2124215-2023-45246
• Device Sequence Number: 12746827
• Product Code: QEW
• UDI-Device Identifier: 00850029546054
• UDI-Public: 00850029546054
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210911
• 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): 11/27/2023

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: 12/28/2023
• Device Lot Number: 0000200071
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown