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: 2143321 · Received June 29, 2011

    Report

    Report Number
    2939204-2011-00334
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT THE COIL BROKE AFTER RESISTANCE WAS ENCOUNTERED AT THE HUB OF THE MICROCATHETER DURING WITHDRAWAL OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED AND THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS SO A DEFINITIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE IT IS MOST LIKELY THAT OPERATIONAL CONTEXT WAS THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL BROKE AS IT WAS BEING REMOVED FROM THE PATIENT DUE RESISTANCE ENCOUNTERED DURING THE REMOVAL OF THE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT AND NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL BROKE AS IT WAS BEING REMOVED FROM THE PATIENT DUE RESISTANCE ENCOUNTERED DURING THE REMOVAL OF THE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT AND NO OTHER INFORMATION HAS BEEN 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 BOSTON SCIENTIFIC - CORK M00334816400 14161812

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR 1018 MICROCATHETER (BOSTON SCIENTIFIC)