BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC SYNERG POWER SUPPLY

    MDR report key: 886082 · Received September 14, 2006

    Report

    Report Number
    6000078-2004-00261
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    October 11, 2004
    Report Date
    October 14, 2004
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    K991134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K) #: K001083. THE DEVICE IN QUESTION WAS RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS. UPON RECEIPT OF THE DEVICE, THERE WAS NO APPARENT PHYSICAL DAMAGE OR MISSING COMPONENTS TO THE DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTING, INCLUDING DETACHMENT SIMULATION. THE DATA RETRIEVED FROM THE SUBJECT DEVICE INDICATED THAT THE LAST 10 OUT OF 11 DETACHMENTS WERE SUCCESSFUL AND DO NOT INDICATE EVIDENCE OF A MELTED CATHETER. DATA SET 11 EXHIBITED NO CURRENT, WHICH COULD INDICATE NO GROUND LOOP OR COIL WAS ATTACHED TO THE UNIT. AS A RESULT OF THE INVESTIGATION, BOSTON SCIENTIFIC COULD NOT DUPLICATE THE USER'S EXPERIENCE. THEREFORE, BOSTON SCIENTIFIC COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. HOWEVER, IT SHOULD BE NOTED THAT THE PHENOMENON THAT THE USER REPORTED COULD POTENTIALLY BE CAUSED BY USING NON-BOSTON SCIENTIFIC COILS IN CONJUNCTION WITH THIS DEVICE, BUT AFTER SEVERAL ATTEMPTS TO GATHER THIS INFO FROM THE PHYSICIAN, BOSTON SCIENTIFIC COULD NOT CONFIRM THE BRAND OF COILS USED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: THE PHYSICIAN REPORTED DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE "POWER SUPPLY MELTED THE CATHETER TIP". THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS PHENOMENON. THE PHYSICIAN DID NOT DISCLOSE ANY FURTHER DETAILS REGARDING THIS ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC SYNERG POWER SUPPLY POWER SUPPLY HCG NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP 451007-4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *