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

Lot Number	0000247769
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath was difficult to remove.A wolf thrombectomy sheath was used in a thrombectomy procedure.During sheath removal, there was a fair amount of resistance.The procedure was completed with this device.There were no patient complications.

• Brand Name: WOLF THROMBECTOMY SHEATH
• 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: 17646476
• Report Number: 2124215-2023-45221
• Device Sequence Number: 5633340
• Product Code: QEW
• UDI-Device Identifier: 00850029546153
• UDI-Public: 00850029546153
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 08/29/2023

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: 09/17/2023
• Device Lot Number: 0000247769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown