BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    MDR report key: 12194237 · Received July 19, 2021

    Report

    Report Number
    3005168196-2021-01604
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 19, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00815948022348
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523. 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 FISTULA UPPER EXTREMITY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CATD WOULD NOT ADVANCE THROUGH THE VALVE OF THE SHEATH, AND THE TIP OF THE CATD BENT. IT WAS REPORTED AN INTRODUCER HAD BEEN USED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089473 INDIGO SYSTEM CATD ASPIRATION CATHETER DXE DXE PENUMBRA, INC. CATD-S H11088 00815948022348

    Patients

    Seq Age Sex Outcome Treatment
    1