BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2020344 · Received March 16, 2011

    Report

    Report Number
    2939204-2011-00132
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUL REVIEW OF THE INFORMATION AVAILABLE CONCLUDED THAT THE PROXIMAL CONTACT IS NOT A CONTIGUOUS PART THAT FORMS THE PUSHER WIRE, BUT A SUBCOMPONENT LOCATED AT THE PROXIMAL END OF THE PUSHER WIRE. THE PROXIMAL CONTACT REMAINS OUTSIDE OF THE PATIENT AT ALL TIMES DURING THE PROCEDURE. THEREFORE BASED ON THIS INFORMATION THE MANUFACTURER HAS DETERMINED THAT THIS EVENT DOES NOT MEET THE EQUIVALENT OF A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUSHER WIRE PROXIMAL CONTACT WAS FOUND TO HAVE FRACTURED WHEN IT WAS REMOVED FROM THE DETACHMENT SYSTEM OUTSIDE THE PATIENT. THE SAME ISSUE OCCURRED WITH A SECOND DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUSHER WIRE PROXIMAL CONTACT WAS FOUND TO HAVE FRACTURED WHEN IT WAS REMOVED FROM THE DETACHMENT SYSTEM OUTSIDE THE PATIENT. THE SAME ISSUE OCCURRED WITH A SECOND DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK595

    Patients

    Seq Age Sex Outcome Treatment
    1 INZONE DETACHABLE SYSTEM (BOSTON SCIENTIFIC)