BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDC - INTERLOCKING DETACHABLE COIL

    MDR report key: 1130945 · Received August 21, 2008

    Report

    Report Number
    2134265-2008-02403
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE COIL REMAINS IN THE PATIENT; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BRONCHIAL ARTERY EMBOLIZATION PROCEDURE, COIL DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH COUGHING UP BLOOD. THE BRONCHIAL ARTERY WAS ACCESSED, AND A 5FR GUIDE CATHETER WAS USED. A RENEGADE 18 MICRO CATHETER WAS USED. FIRST, AN IDC18 3X10 COIL WAS DEPLOYED. THEN, TWO FIBERED PLATINUM 2X20MM COILS WERE DEPLOYED. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THIS 3X10CM IDC COIL, IT DETACHED AND DEPLOYED IN THE MAIN ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE THE COIL WITH A GOOSENECK SNARE HOWEVER THE COIL WAS STRETCHED AND TORN DURING THE ATTEMPT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. PATIENT IS UNDER OBSERVATION. THE BLEEDING WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS AN OPINION OF THE PHYSICIAN THAT IT MAY HAVE BEEN A SPASM IN THE BRONCHIAL ARTERY THAT CAUSED THE COIL TO NOT DETACH AND DEPLOY PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDC - INTERLOCKING DETACHABLE COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC NA 8909501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other