BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 8

    MDR report key: 7599104 · Received June 13, 2018

    Report

    Report Number
    3005168196-2018-01178
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 15, 2018
    Report Date
    May 15, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016252
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2018-001179. THE HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8S). DURING THE PROCEDURE, THE TIPS OF TWO CAT8S BECAME CRIMPED AS THE PHYSICIAN ATTEMPTED TO ADVANCE THEM INTO A NON-PENUMBRA CATHETER. THE CAT8S WERE THEREFORE NOT USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439694 INDIGO SYSTEM ASPIRATION CATHETER 8 DXE DXE PENUMBRA, INC. F82180 00814548016252

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR