BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 16098748 · Received January 4, 2023

    Report

    Report Number
    3005168196-2023-00002
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 10, 2022
    Report Date
    January 4, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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, AN INVESTIGATION CANNOT BE PERFORMED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH AND A GUIDEWIRE (300CM 0.014). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CATRX. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE CATRX, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER THE CATRX WAS REMOVED, THE DISTAL END OF THE CATRX WAS NOTICED TO BE DISCONNECTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DISTAL END OF THE CATRX USING A SNARE DEVICE AND ASPIRATION; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THEREFORE, AN OPEN SURGERY VIA CUTDOWN TECHNIQUE WAS PERFORMED TO REMOVE THE BROKEN PIECE OF THE CATRX. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909413 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. F00002693 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention