BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 6407375 · Received March 15, 2017

    Report

    Report Number
    3005168196-2017-00372
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 14, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K): 160533. PLEASE NOTE THAT THE DEVICE IS NO LONGER AVAILABLE FOR RETURN AS MENTIONED IN THE INITIAL MDR; THEREFORE, THE MDR WAS UPDATED ACCORDINGLY. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT6 INTO A NON-PENUMBRA SHEATH; CONSEQUENTLY THE TIP OF THE CAT6 BECAME CRUSHED. THEREFORE, THE SHEATH AND THE CAT6 WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA SHEATH AND A NEW CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189099 INDIGO SYSTEM ASPIRATION CATHETER 6 DXE DXE PENUMBRA, INC. F71418 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR