BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE¿ THROMBECTOMY SYSTEM

    MDR report key: 17063712 · Received June 5, 2023

    Report

    Report Number
    3014687026-2023-00005
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 16, 2023
    Report Date
    August 9, 2023
    Manufacturer
    SURMODICS INC
    Product Code
    QEW
    UDI-DI
    00812339030296
    PMA / PMN Number
    K192814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H3: DEVICE ANALYSIS OF THE BASKET WIRE CONFIRMED THE REPORTED ISSUE. THE BASKET WIRE, DELIVERY CATHETER, AND FUNNEL CATHETER WERE RECEIVED FOR ANALYSIS. THE DISTAL BASKET WAS NOT PRESENT ON THE BASKET WIRE AND WAS DISCARDED BY THE SITE. INSPECTION OF THE DISTAL BASKET COLLAR AND WELD FOUND THE THREE STRUTS HAD FRACTURED AT THE COLLAR. THE REPORTED FAILURE MODE WAS CONSISTENT WITH A KNOWN DEVICE ISSUE.

    Description of Event or Problem · 0

    THE DEVICE WAS BEING USED DURING A THROMBECTOMY PROCEDURE WITH POPLITEAL ARTERY ACCESS. THE DEVICE WAS USED FOR A PASS IN THE ILIAC ARTERY WITH GREAT RESULTS. A SECOND PASS WAS PERFORMED IN THE MID POSTERIOR TIBIAL ARTERY. PRIOR TO WITHDRAWAL, BOTH BASKETS WERE VISUALIZED IN THE FUNNEL VIA FLUOROSCOPY. WHEN THE FUNNEL CATHETER AND BASKET WIRE WERE REMOVED AND EXPOSED, ONLY ONE OF THE TWO BASKETS REMAINED (DISTAL BASKET SEPARATION). THE DEVICE FUNNEL WAS FLUSHED AND THE SECOND BASKET WAS MISSING. IMAGING WAS PERFORMED AND THE BASKET REMAINED IN THE PATIENT, MID-POSTERIOR TIBIAL. THE BASKET HAD MIGRATED BACK DOWN BECAUSE BOTH BASKETS WERE IN THE FUNNEL IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA)/POPLITEAL ARTERY BEFORE REMOVAL. THE PHYSICIAN WAS UNABLE TO ASPIRATE OR SNARE THE BASKET OUT AND IT REMAINED IN THE PATIENT. BECAUSE THERE WAS NO DISTAL FLOW IN THE POPLITEAL ARTERY, THE PHYSICIAN CHOSE TO LEAVE. NO RESISTANCE WAS EXPERIENCED DURING DEVICE INSERTION OR REMOVAL. THE TARGET LESION HAD NO CALCIFICATION AND THE DEVICE AS NOT PLACED THROUGH ANY STENTS. A HIGH AMOUNT OF ORGANIZED THROMBUS WAS REMOVED; RANGING FROM SUBACUTE TO CHRONIC. AN ADDITIONAL CUTDOWN PROCEDURE WAS PERFORMED THE NEXT DAY TO REMOVE THE BASKET. THERE WAS NO REPORTED PROCEDURE DELAY. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094749 POUNCE¿ THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW SURMODICS INC PTS-0607-7F135 FG220021 00812339030296

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention