MAUDE Adverse Event Report: SURMODICS INC POUNCE VENOUS THROMBECTOMY SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	VTS-0018-09010
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The pounce venous device was used in the patient's left and right legs for thrombectomy treatment.A 12fr standard introducer was used at both popliteal access points.Approximately four to five device passes were performed in the left leg before moving to the right leg.Prior to insertion into the right popliteal artery, the device was deemed acceptable for further passes.After the first pass, the physician encountered resistance pulling the basket back into the introducer sheath and was unable to bring the basket down sufficiently with the handle's cam or rear slide.Upon attempt to re-sheath the basket with the outer sheath the basket further deformed, and it was confirmed that the handle was no longer able to communicate with the distal end of the device (inability to expand/collapse basket).Further attempts caused the mid-shaft to fully fracture, separating the handle from the device leaving just the shaft of the device.Several attempts to recapture or remove the basket were unsuccessful, ultimately requiring a venous cut-down at the access site to remove the basket.The basket/catheter was successfully removed, and it was noted that the basket was packed full with clot.Patient was reported to be doing well post procedure yesterday evening.
Additional Manufacturer Narrative
Correction: g4 510(k) updated to k201705 from k192814.

• Brand Name: POUNCE VENOUS THROMBECTOMY SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer (Section G): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 19332250
• Report Number: 3014687026-2024-00001
• Device Sequence Number: 17893546
• Product Code: QEW
• UDI-Device Identifier: 00812339030319
• UDI-Public: 00812339030319
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201705
• 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): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2024
• Device Model Number: VTS-0018-09010
• Device Lot Number: 23H034AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown