BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CAT RX ASPIRATION CATHETER

    MDR report key: 12642416 · Received October 15, 2021

    Report

    Report Number
    3005168196-2021-02299
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 9, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CATRX REVEALED THAT THE GUIDEWIRE LUMEN WAS PUNCTURED. IF THE GUIDEWIRE IS FORCEFULLY ADVANCED THROUGH THE CATRX GUIDEWIRE LUMEN AT AN EXTREME ANGLE, THE GUIDEWIRE MAY PUNCTURE THE LUMEN. THIS DAMAGE LIKELY CONTRIBUTED TO THE REPORTED COMPLAINT DURING THE PROCEDURE. FURTHER EVALUATION OF THE DEVICE REVEALED A FRACTURE, AND THE PROXIMAL FRACTURED SEGMENT WAS NOT RETURNED FOR EVALUATION. THE RETURNED DISTAL FRACTURED SEGMENT WAS KINKED. THIS DAMAGE WAS NOT INDICATED IN THE COMPLAINT, AND THEREFORE, WAS LIKELY INCIDENTAL. DUE TO THE RETURNED DAMAGE, THE DEVICE WAS UNABLE TO BE FUNCTIONALLY TESTED. 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 USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), NON-PENUMBRA GUIDE (6F), AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT PASS THROUGH THE CATRX GUIDEWIRE LUMEN. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539421 INDIGO SYSTEM CAT RX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F102982 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male