BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK?

    MDR report key: 3131870 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-04134
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2013. (B)(4). DEVICE EVALUATED BY MFR: 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 AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING TREATMENT OF A VARICOCELE. A NON BSC MICROCATHETER WAS POSITIONED AND THE 6.0MM X 20CM INTERLOCK COIL WAS ADVANCED. THE COIL DETACHED WITHIN THE MICROCATHETER AT AN UNSPECIFIED LOCATION. THEY PUSHED THE COIL OUT; HOWEVER, WHEN IT WAS DEPLOYED, THE COIL DID NOT FORM AS EXPECTED. THEY DECIDED IT WAS FINE DUE TO THE ANATOMICAL LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235242 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361570

    Patients

    Seq Age Sex Outcome Treatment
    1