BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 11740002 · Received April 28, 2021

    Report

    Report Number
    3005168196-2021-00898
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2021-00894, 3005168196-2021-00895, 3005168196-2021-00896, 3005168196-2021-00897.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A TRANS-ARTERIAL COIL EMBOLIZATION PROCEDURE FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, RUBY COIL LPS, PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT HAD POSSIBLE STENOSIS AND NARROWED VESSELS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE PACKING COIL LP AS THE FIRST COIL, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER. AFTER POSITIONING THE PACKING COIL LP IN THE TARGET LOCATION, THE COIL COULD NOT BE DETACHED USING THE HANDLE. IT WAS ALSO REPORTED THAT SEVERAL ATTEMPTS TO MANUALLY DETACH THE COIL FAILED; THEREFORE, THE PACKING COIL LP WAS REMOVED. WHILE ADVANCING A 2X4 RUBY COIL LP (F102505) THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO USE A SMART COIL WHICH HAD A SMALLER DIAMETER THAN THE PREVIOUS COILS. HOWEVER, RESISTANCE WAS ALSO ENCOUNTERED WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER AND THE SMART COIL WOULD NOT ADVANCE BEYOND THE DISTAL END. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY OF THE SMART COIL KINKED DURING THE ADVANCEMENT ATTEMPT. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED THE MICROCATHETER MORE DISTAL TO POSSIBLE STENOSIS OR NARROWED VASCULATURE AND ATTEMPTED TO ADVANCE A 2X2 RUBY COIL LP (F102504); HOWEVER, THE RUBY COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN EMBOLIC AGENT (GLUE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634570 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. SCH1 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR