MAUDE Adverse Event Report: SURMODICS INC. POUNCE VENOUS THROMBECTOMY SYSTEM; Peripheral mechanical thrombectomy with aspiration

Model Number	VTS-0018-09010
Medical Device Problem Codes	Break (1069); Material Separation (1562); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The pounce venous device was used to treat a patient's lower leg extremity with sub-acute/chronic morphology with no significant tortuosity.It was reported that after 3-4 passes, upon removal of the device, a piece of the basket had separated from the device.It was reported that the physician did experience resistance while withdrawing the device from the body.During the investigation of the complaint, it was confirmed that the physician did not defeat the hemostasis valve on the 12fr pounce sheath device while withdrawing the pounce venous device from the body which could have contributed to the resistance felt upon withdrawal of the device.The physician was able to remove the clot with a second device in conjunction with balloon venoplasty.There was no reported harm to the patient or significant procedure delay.
Additional Manufacturer Narrative
The device was not returned for analysis.The investigation included utilizing a pounce venous device with a simulated use model with lab made clot.The failure mode could not be replicated after 4 passes through a closed 12fr pounce sheath hemostasis valve.The cause of the reported issue could not be confirmed based on the available information.

• Brand Name: POUNCE VENOUS THROMBECTOMY SYSTEM
• Common Device Name: Peripheral mechanical thrombectomy with aspiration
• Manufacturer (Section D): SURMODICS INC.; 7905 golden triangle drive; suite 120; eden prairie MN 53344
• Manufacturer Contact: peter bather ; surmodics inc. 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007548
• MDR Report Key: 23732649
• Report Number: 3014687026-2025-00007
• Device Sequence Number: 10615615
• Product Code: QEW
• UDI-Device Identifier: 00812339030791
• UDI-Public: 00812339030791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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 Model Number: VTS-0018-09010
• Device Lot Number: FG250028
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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
• Patient Sex: Unknown