BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 1891403 · Received November 4, 2010

    Report

    Report Number
    2134265-2010-05116
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TREATMENT PROCEDURE THE COIL PREMATURELY DETACHED FROM THE INTRODUCER WIRE. THE INTENDED LOCATION WAS THE INFERIOR MESENTERIC ARTERY. THE PHYSICIAN INTRODUCED THE 2/6MM X 8CM VORTX DIAMOND IDC OCCLUSION SYSTEM INTO A RENEGADE MICRO-CATHETER. IT WAS NOTED THAT THE INTERLOCK COIL DETACHED PREMATURELY FROM THE INTRODUCER WIRE. THE PHYSICIAN RETRACTED THE INTERLOCK WIRE AND USED A COIL FLASHER AND A 3MM J-WIRE. THIS COIL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361770 0012993509

    Patients

    Seq Age Sex Outcome Treatment
    1 MICRO-CATHETER: RENEGADE