BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 3233595 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-05028
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 EMBOLIZATION PROCEDURE, INABILITY OF THE COIL TO BE RECAPTURED INTO THE MICROCATHETER OCCURRED. THE TARGET LESION WAS LOCATED IN A BRANCH OF THE HEPATIC ARTERY. A 4MM X 15 CM F-IDC DETACHABLE COIL WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, THE COIL WAS NOT FULLY DEPLOYED AND AN ATTEMPT TO RECAPTURE THE COIL INTO THE RENEGADE MICROCATHETER WAS DONE; HOWEVER, IT WAS UNABLE TO BE RECAPTURED. THE COIL AND THE MICROCATHETER WERE THEN REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE BUT WITH THE SAME MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334630 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361530 0014922492

    Patients

    Seq Age Sex Outcome Treatment
    1