BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    MDR report key: 1551162 · Received November 11, 2009

    Report

    Report Number
    2939204-2009-00833
    Event Type
    Malfunction
    Date Received
    November 11, 2009
    Date of Event
    September 24, 2009
    Report Date
    October 13, 2009
    Manufacturer
    NEUROVASCULAR DIV. BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY PROVIDED THE LOT NUMBER FOR THE COIL THAT BROKE DURING THE PROCEDURE. A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. NO OTHER INFORMATION WAS PROVIDED BY THE USER FACILITY, SO BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION, THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K042539.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION OF THE ANEURYSM, THE DEVICE BROKE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT AND NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION OF THE ANEURYSM, THE DEVICE BROKE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PT AND NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI DEVICE, NEUROVASCULAR EMBOLIZATION HCG NEUROVASCULAR DIV. BOSTON SCIENTIFIC CORP M003347509SR0 11914373

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR SIXTEEN GDC COILS (BOSTON SCIENTIFIC)