BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 11953385 · Received June 7, 2021

    Report

    Report Number
    3005168196-2021-01272
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    December 1, 2020
    Report Date
    July 20, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT6 CONFIRMED KINKS ON THE MIDSHAFT AND DISTAL END. IF THE DEVICE IS FORCEFULLY MANIPULATED AGAINST RESISTANCE OR IS OTHERWISE MISHANDLED AT EXTREME ANGLES DURING USE, DAMAGE SUCH AS KINKS MAY OCCUR. DURING FUNCTIONAL TESTING, THE CAT6 WAS UNABLE TO BE ADVANCED THROUGH A DEMONSTRATION RHV DUE TO THE DAMAGE ON THE DISTAL SHAFT. 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND SHEATH. DURING THE PROCEDURE, THE CAT6 WAS NOTICED TO BE KINKED AT THE MIDSHAFT AND DISTAL END AFTER THE FIRST ASPIRATION. THEREFORE, THE CAT6 WAS NOT FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BALLOONING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841306 INDIGO SYSTEM ASPIRATION CATHETER 6 QEW QEW PENUMBRA, INC. CAT6 F87552 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1