BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 10782564 · Received November 3, 2020

    Report

    Report Number
    3005168196-2020-01884
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 2020
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, 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.

    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 PERINEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CATRX INTO THE TARGET VESSEL, THE PHYSICIAN NOTICED THE CATRX BECAME BROKEN IN HALF INTO TWO PIECES. THEREFORE, THE PHYSICIAN PULLED AND REMOVED THE PROXIMAL HALF OF THE CATRX. A GOOSE NECK SNARE AND ENSNARE WAS THEN USED TO REMOVE THE DISTAL HALF OF THE CATRX. SUBSEQUENTLY, THE PATIENT EXPIRED. THE PATIENT¿S DEATH WAS UNRELATED TO THE CATRX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245633 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX, QEW QEX PENUMBRA, INC. CATRXKIT F93673 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention