BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDC¿

    MDR report key: 3033695 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02102
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). 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 CONSIDERED USER RELATED AS CONTINUOUS FLUSH WAS NOT MAINTAINED AND AN INCORRECT CATHETER WAS USED PER THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, A COIL SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. AN 18 6MM X 20CM IDC INTERLOCK COIL WAS ADVANCED INTO A 0.021INCH 150CM RENEGADE MICROCATHETER WITHOUT ISSUE. THE PHYSICIAN NOTED THAT THE SIZE OF THE COIL DIDN'T MATCH THE LESION AND REMOVED COIL FROM THE MICROCATHETER. "THE COIL SEPARATED AT NOT INTERLOCKED AREA". THE COIL REMAINS IN THE PATIENT AT AN UNINTENDED LOCATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COILS AND ANOTHER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136363 IDC¿ DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M0013606200 15703852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention