BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 18632860 · Received February 2, 2024

    Report

    Report Number
    3005168196-2024-00036
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    January 7, 2024
    Report Date
    February 2, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K220683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GLIDEWIRE. DURING THE PROCEDURE, A GLIDEWIRE WAS ADVANCED DOWN THE ANTERIOR TIBIAL ARTERY AND PAST A LESION. THE PHYSICIAN THEN ADVANCED A CATRX TO THE TARGET LOCATION AND COMPLETED ONE PASS IN THE POSTERIOR TIBIAL ARTERY. WHILE ATTEMPTING TO MAKE THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CATRX PAST THE LESION IN THE ANTERIOR TIBIAL ARTERY. IT WAS NOTED THAT THE PHYSICIAN USED EXCESSIVE FORCE TO ADVANCE THE CATRX; SUBSEQUENTLY, THE CATRX BUCKLED NEAR THE MIDSHAFT AND THE DISTAL END. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CATRX FROM THE PATIENT. AFTER REMOVAL, THE DISTAL END OF THE CATRX WAS NOTICED TO BE FRACTURED INSIDE THE PATIENT AND A PORTION OF THE GLIDEWIRE WAS ALSO NOTICED TO BE WRAPPED AROUND THE CATRX NEAR THE FRACTURE. THE PHYSICIAN USED A SNARE DEVICE TO RETRACT THE FRACTURED CATRX INTO THE SHEATH TO WHERE THE SHEATH ENTERED THE PATIENT. THE PHYSICIAN THEN PERFORMED A SURGICAL CUT DOWN TO REMOVE THE FRACTURED CATRX. THE PROCEDURE ENDED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232725 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F00006940 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention