BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 3174914 · Received June 18, 2013

    Report

    Report Number
    2134265-2013-04058
    Event Type
    Injury
    Date Received
    June 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. CITATION; WORLD J GASTROENTEROL 2012 APRIL 28; 18(16): 1940-1945 ISSN 1007-9327 (PRINT) ISSN 2219-2840. PREOPERATIVE MICROCOIL EMBOLIZATION OF THE COMMON HEPATIC ARTERY FOR PANCREATIC BODY CANCER. TAKASAKA I ET AL . BALLOON INFLATED TAE OF CHA. SEE ATTACHED FILE: LITERATURE_TAKASAKA ET AL. BSC ID: A00392340 / TW#2769804 - ATTACHMENT: [TAKASAKA_ET_AL_PREOPERATIVE.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DURING A MICROCOIL TREATMENT PROCEDURE, AN INTERLOCK COIL MIGRATED TO THE PROPER HEPATIC ARTERY. THE MICROCOIL WAS WITHDRAWN BY AN INFLATED MICROBALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275159 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK UNK716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention