BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 6027485 · Received October 13, 2016

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    3005168196-2016-01461
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 14, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) WAS OVALIZED APPROXIMATELY 124.0 AND 127.0 CM FROM THE HUB. THE CAT6 HAD MULTIPLE CONSECUTIVE KINKS ALONG ITS DISTAL SHAFT, BEGINNING APPROXIMATELY 127.0 CM FROM THE HUB THE DISTAL TIP. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED THE CAT6 HAD MULTIPLE CONSECUTIVE KINKS IN ITS DISTAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO REPEATED FORCEFUL ADVANCEMENT OF THE CAT6 AGAINST RESISTANCE. FURTHER EVALUATION REVEALED THE CAT6 WAS OVALIZED IN ITS DISTAL SHAFT. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO FORCEFUL GRIPPING OR MANIPULATION OF THE CAT6 DURING PREPARATION FOR USE. THE SHEATH MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. 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.

    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 ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE TIP OF THE CAT6 BECAME KINKED WHILE BEING INSERTED INTO THE SHEATH; THEREFORE, IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678099 INDIGO SYSTEM ASPIRATION CATHETER 6 DXE DXE PENUMBRA, INC. F69157 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR