BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11904542 · Received May 28, 2021

    Report

    Report Number
    3005168196-2021-01185
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 3, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CATRX CONFIRMED A FRACTURE ON ITS PROXIMAL SHAFT. IF THE CATRX IS MANIPULATED AT EXTREME ANGLES DURING ADVANCEMENT, THE CATHETER MAY BECOME KINKED. IF THE KINKED CATHETER IS FURTHER MANIPULATED, THE KINK MAY WORSEN TO A FRACTURE. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A PENUMBRA ENGINE (ENGINE), A 6F NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATRX OVER THE GUIDEWIRE THROUGH THE GUIDEWIRE LUMEN AND THE SHEATH TO THE TARGET VESSEL WITH RESISTANCE AND THEN CONNECTED THE CATRX TO THE ENGINE. WHEN ASPIRATION WAS TURNED ON, THE PHYSICIAN HEARD A ¿HISSING¿ SOUND AND THEN NOTICED A CRACK IN THE CATRX. THEREFORE, THE CATRX WAS REMOVED. UPON REMOVAL OF THE ENTIRE CATRX, THE PHYSICIAN NOTICED THAT THE CATRX WAS BROKEN IN THREE PLACES ALONG ITS LENGTH. THE PROCEDURE WAS COMPLETED USING OTHER CATHETERS AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800616 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. CATRXKIT F89204 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR