BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2022139 · Received March 17, 2011

    Report

    Report Number
    2939204-2011-00114
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. INSPECTION OF THE RETURNED DEVICE UNDER MICROSCOPY NOTED THAT THE PROXIMAL CONTACT HAD DETACHED FROM THE PUSHER WIRE. THE PROXIMAL CONTACT IS A SEPARATE COMPONENT OF THE DEVICE SO THE REPORTED EVENT THAT THE PUSHER WIRE WAS BROKEN WAS NOT CONFIRMED. NO OTHER ANOMALIES WERE NOTED TO THE DEVICE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION IT IS MOST PROBABLE THAT OPERATIONAL CONTEXT WAS THE CAUSE OF THE PROXIMAL CONTACT BECOMING DETACHED FROM THE PUSHER WIRE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    FRICTION WAS ENCOUNTERED WHILE THE PHYSICIAN WAS INSERTING THE SUBJECT COIL IN THE MICROCATHETER. AS THE PHYSICIAN REMOVED THE INTRODUCER SHEATH, HE NOTED THAT THE APPROXIMATELY 3CM OF THE DELIVERY WIRE PROXIMAL END BROKE. THE COIL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING OTHER OF THE SAME TYPE OF COILS. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT WHO WAS REPORTEDLY IN A GOOD CONDITION.

    Description of Event or Problem · 1

    FRICTION WAS ENCOUNTERED WHILE THE PHYSICIAN WAS INSERTING THE SUBJECT COIL IN THE MICROCATHETER. AS THE PHYSICIAN REMOVED THE INTRODUCER SHEATH, HE NOTED THAT THE APPROXIMATELY 3CM OF THE DELIVERY WIRE PROXIMAL END BROKE. THE COIL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING OTHER OF THE SAME TYPE OF COILS. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT WHO WAS REPORTEDLY IN A GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035432040 0013992847

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)| SYNCHRO 014 GUIDEWIRE (BOSTON SCIENTIFIC)