BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEGADE STC 18 MICROCATHETER

    MDR report key: 2119107 · Received June 9, 2011

    Report

    Report Number
    2134265-2011-02223
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQO
    PMA / PMN Number
    K023681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-02222. IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE COIL DETACHED PREMATURELY AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS UNDERGOING REPAIR OF A "HUGE" ANEURYSM IN THE SEVERELY TORTUOUS GASTRODUODENAL ARTERY (GDA). THE GDA OUTFLOW WAS COILED UTILIZING 3 NON BSC DEVICES AND 2 FIBERED INTERLOCK DETACHABLE COILS (F-IDC). A THIRD F-IDC WAS THEN INTENDED TO BE PLACED IN THE GDA AND EXTENDING INTO THE ANEURYSM. THE RENEGADE STC MICROCATHETER WAS CURVED INTO THE ANEURYSM AND THE F-IDC WAS IN THE DISTAL END OF THE CATHETER. THE CATHETER PULLED BACK AND "FLIPPED AROUND" AND THE COIL DETACHED IN AN UNINTENDED LOCATION. THE PROCEDURE WAS CONTINUED AND 15 ADDITIONAL F-IDCS OF VARIOUS SIZES WERE IMPLANTED IN THE ANEURYSM. THE PHYSICIAN WAS CONCERNED WITH THE LOCATION OF THE DETACHED COIL, AS IT WAS CLOSE TO THE SUPERIOR MESENTERIC ARTERY, AND HE DECIDED TO SNARE IT. DIFFICULTY WAS EXPERIENCED DURING REMOVAL OF THE COIL AS A PORTION OF IT BECAME CAUGHT ON THE NON BSC ANGIOGRAPHIC CATHETER. THE COIL BECAME STRETCHED, BUT THE PHYSICIAN "PULLED A LITTLE" AND WAS ABLE TO REMOVE IT SUCCESSFULLY. IT WAS NOTED THAT THE PHYSICIAN WAS HAPPY WITH THE FINAL RESULT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS "DOING WELL" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEGADE STC 18 MICROCATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - CORK M001181400 14096634

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SIMS ANGIOGRAPHIC CATHETER| BSC F-IDCS