BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 12783691 · Received November 9, 2021

    Report

    Report Number
    3005168196-2021-02535
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 9, 2021
    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
    NY, 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL AND PERONEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN USED THE CATRX TO ASPIRATE CLOT OUT FROM THE TARGET LOCATION. SUBSEQUENTLY, WHILE RETRACTING THE CATRX FROM THE PATIENT, THE CATRX BROKE INTO TWO PIECES IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THEREFORE, THE PHYSICIAN ADVANCED A NON-PENUMBRA BALLOON CATHETER TO CAPTURE AND RETRACT THE BROKEN PIECES OF THE CATRX BACK INTO THE SHEATH FROM SFA. THE SHEATH AND BALLOON WERE THEN REMOVED TOGETHER CONTAINING THE BROKEN PIECES OF THE CATRX. THE PROCEDURE HAD 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
    1677162 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. CATRXKIT F104646 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention