BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CAT 6 ASPIRATION CATHETER

    MDR report key: 7601399 · Received June 14, 2018

    Report

    Report Number
    3005168196-2018-01167
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE HOSPITAL DISPOSED OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: DXE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT 6 ASPIRATION CATHETER (CAT6). DURING THE PROCEDURE, THE TIP OF THE CAT6 BECAME CRUSHED AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE CAT6 INTO A NON-PENUMBRA SHEATH. THE CAT6 WAS THEREFORE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444454 INDIGO SYSTEM CAT 6 ASPIRATION CATHETER DXE DXE PENUMBRA, INC. F81548 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1