BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 3063492 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02624
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, THE COIL WAS DETACHED. THE TARGET LESION WAS UNKNOWN. UNKNOWN CATHETER WAS PLACED AND THE PHYSICIAN ADVANCED A .035 IDC INTERLOCK COIL THROUGH THE CATHETER. DURING REMOVAL, THE INTERLOCKING ARM WAS DETACHED INTO THE CATHETER. THE PHYSICIAN PULLED OUT THE PROXIMAL END OF THE DELIVERY SYSTEM WITHOUT LOOKING AND HIT THE ROD. THE COIL SHUT DOWN STRAIGHT WHILE THE PHYSICIAN INJECTED IT. MULTIPLE DEVICES WERE USED TO RETRIEVE THE COIL. THEY WERE ABLE TO REMOVE THE COIL AS A UNIT FROM THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164491 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK UNK716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention