BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 3193670 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04344
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 PRECLINICAL PROCEDURE ON A DOMESTIC SWINE, A PUSHER WIRE FRACTURED. THE ANATOMY OF THE TARGET LESION WAS MILDLY TORTUOUS. A NON-BSC 5F, JR 5.0 GUIDE CATHETER AND A RENEGADE FIBER BRAIDED MICROCATHETER WERE INTRODUCED. A 22 MM X 60 CM INTERLOCK 018 EMBOLIC COIL WAS THEN DELIVERED AND DEPLOYED SUCCESSFULLY. DURING DELIVERY, THE OPERATOR NOTED INCREASED RESISTANCE AND UPON REMOVAL OF THE PUSHER WIRE, IT WAS FOUND THAT THE WIRE WAS BROKEN, PERHAPS DUE TO FOLDING BACK IN ON ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294797 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK297

    Patients

    Seq Age Sex Outcome Treatment
    1 MERITMEDICAL 5F, JR 5.0 PERFORMA .038¿ GUIDE CATH| BSC RENEGADE FIBER BRAIDED MICROCATHETER