BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE ¿ XL THROMBECTOMY

    MDR report key: 22476060 · Received July 10, 2025

    Report

    Report Number
    3014687026-2025-00003
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 13, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    QEW
    UDI-DI
    00812339030807
    PMA / PMN Number
    K241362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TO DATE, THE DEVICE HAD NOT BEEN RETURNED. IF RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED FOR ANALYSIS RESULTS.

    Description of Event or Problem · 0

    A PATIENT PRESENTED WITH NO FLOW THROUGH A 6MM GRAFT FROM THE RIGHT COMMON FEMORAL ARTERY (RCFA) TO THE POSTERIOR TIBIAL ARTERY (PT). LEFT COMMON FEMORAL ACCESS WAS OBTAINED USING A 7F SHEATH, LATER EXCHANGED FOR AN 8F SHEATH TO ACCOMMODATE MULTIPLE THROMBECTOMY PASSES. TWO SUCCESSFUL PASSES WERE COMPLETED USING THE POUNCE XL IN CHRONIC RIGHT-SIDED VESSELS AND THE OCCLUDED BYPASS SEGMENT. DURING A THIRD PASS THROUGH THE NATIVE RCFA, A SUBSTANTIAL QUANTITY OF ORGANIZED THROMBUS WAS CAPTURED IN THE DEVICE FUNNEL AND BASKETS. UPON ATTEMPTING TO REMOVE THE LOADED SYSTEM THROUGH THE 8F SHEATH, RESISTANCE WAS ENCOUNTERED. THIS WAS PRESUMED TO BE DUE TO THE THROMBUS VOLUME BURDENING THE LUMEN CLEARANCE OF THE SHEATH. ADDITIONAL TRACTION WAS APPLIED, WHICH RESULTED IN THE INNER LINING OF THE SHEATH BEING PULLED INWARD AND/OR STRIPPED. THIS LED TO THE ALLEGED DETACHMENT OF THE FUNNEL AND BASKETS FROM THE POUNCE SYSTEM. DEVICE COMPONENTS (STILL ENGAGED WITH THROMBUS) BECAME ENTRAPPED WITHIN THE VASCULATURE. DURING A FOLLOW-UP PHONE CALL, THE MANUFACTURER REPRESENTATIVE COULD NOT CONFIRM IF THE DEVICE BASKETS HAD SEPARATED FROM THE BASKET WIRE. A SURGICAL CUTDOWN OF THE LEFT COMMON FEMORAL ARTERY WAS REQUIRED TO RETRIEVE THE 8F SHEATH, DEVICE FUNNEL, BASKETS, AND CLOT MATERIAL AS ONE UNIT. THE PROCEDURE WAS ULTIMATELY SUCCESSFUL, WITH BOUNDING DISTAL PULSES NOTED. NO RETAINED DEVICE FRAGMENTS OR PATIENT HARM WAS REPORTED. THE DEVICE WAS DISCARDED POST-PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049387 POUNCE ¿ XL THROMBECTOMY Peripheral mechanical thrombectomy with aspiration QEW SURMODICS, INC. PTS-1011-7F135 FG250027 00812339030807

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention