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: 1974168 · Received January 31, 2011

    Report

    Report Number
    2939204-2011-00051
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THE COIL WAS SOAKED IN SALINE AND CONTINUOUS FLUSH WAS MAINTAINED. ALL MOVEMENTS WERE SLOW AND SMOOTH, BUT FRICTION WAS FELT 15CM FROM THE CATHETERS HUB. THE CATHETER USED HAD AN INTERNAL DIAMETER (ID) OF (B)(4). THE PATIENT'S ANATOMY WAS CONSIDERED MEDIUM IN TORTUOSITY. FINALLY IT WAS CONFIRMED THAT THE PUSHER WIRE BROKE AWAY FROM THE COIL DURING THE DECONTAMINATION PROCESS FOLLOWING THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE COIL WAS RETURNED SEPARATED FROM THE PUSHERWIRE WITHIN THE INTRODUCER SHEATH. THE COIL WAS STRETCHED AT THE PROXIMAL END AND A KINK IN THE INTRODUCER SHEATH WAS NOTED 10CM FROM THE PROXIMAL END. THE DISTAL END OF THE PUSHERWIRE WAS EXTENSIVELY DAMAGED. THE DISPENSER COIL WAS NOT RETURNED. THE STRETCHING ON THE COIL AND DAMAGE TO THE DISTAL END OF THE PUSHERWIRE WOULD INDICATE THAT EXCESS FORCE WAS APPLIED RESULTING IN THE COIL SEPARATING FROM THE PUSHERWIRE. BASED ON THE RESULTS OF THE INVESTIGATION, THE COIL WAS USED WITH AN INCOMPATIBLE CATHETER. THE COIL IN QUESTION IS COMPATIBLE WITH A CATHETER THAT HAS AN ID OF (B)(4). THE CATHETER USED IN CONJUNCTION WITH THIS COIL FOR THIS PROCEDURE HAS AN ID OF (B)(4). THEREFORE THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR AS THE CATHETER USED WAS NOT DIMENSIONALLY COMPATIBLE WITH THE SUBJECT COIL.

    Description of Event or Problem · 1

    UPON ANALYSIS OF THE RETURNED DEVICE, THE COIL WAS FOUND TO BE DETACHED FROM THE PUSHERWIRE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    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 M00334810300 13548113

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR