BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    MDR report key: 15156805 · Received August 3, 2022

    Report

    Report Number
    3005168196-2022-00367
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 3, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K210083 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 CEPHALIC VEIN AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7 D), AN 8F NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CAT7 D WITH THE GUIDEWIRE INTO THE SHEATH USING THE INTRODUCER. NEXT, THE INTRODUCER WAS PUSHED TO THE PROXIMAL END OF THE CAT7 D, THE GUIDEWIRE WAS THEN REMOVED, AND THE PHYSICIAN-INITIATED ASPIRATION. AFTER ADVANCING AND RETRACING MULTIPLE TIMES WITH THE CAT7 D IN THE VESSEL, THE PHYSICIAN DECIDED TO REMOVE THE CAT7 D TO BE FLUSHED. HOWEVER, WHILE RETRACTING, THE PHYSICIAN KINKED THE CAT7 D APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL END AND CONSEQUENTLY, THE CAT7 D BROKE AT THE KINKED LOCATION. THEREFORE, THE CAT7 D WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 D WITH THE SAME INTRODUCER AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798725 INDIGO SYSTEM ASPIRATION CATHETER 7D QEW QEW PENUMBRA, INC. H12833 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female