BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 1972853 · Received January 28, 2011

    Report

    Report Number
    2939204-2011-00041
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY, FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THE PATIENT HAD A TORTUOUS ANATOMY, CONTINUOUS FLUSH WAS MAINTAINED AND THE PHYSICIAN BELIEVES THAT THE COIL GOT HUNG UP ON PREVIOUSLY DEPLOYED COILS IN THE ANEURYSM AND WHEN HE REMOVED THE COIL IN QUESTION IT STRETCHED AND HE THEN ACCIDENTALLY BROKE THE COIL. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. VISUAL INSPECTION OF THE RETURNED DEVICE HAD SHOWN THE COIL TO BE SEPARATED FROM THE PUSHERWIRE. THE PROXIMAL END OF THE MAIN COIL WAS EXTENSIVELY STRETCHED AND THERE WAS A BEND IN THE PUSHERWIRE 10CM FROM THE PROXIMAL END. THE COIL WAS ALSO EXTENSIVELY STRETCHED AT THE PROXIMAL END. THE DISTAL END OF THE COIL WAS STRETCHED AND KINKED. MICROSCOPIC INSPECTION FOUND THE TIP OF THE COIL WAS STILL ATTACHED TO THE DISTAL END OF PUSHER WIRE AND THE MAIN JUNCTION WAS INTACT. NO OTHER ANOMALIES WERE NOTED. PER THE ADDITIONAL INFORMATION RECEIVED THE PHYSICIAN FELT THAT THE COIL MAY HAVE BECOME ENTANGLED ON PREVIOUSLY DEPLOYED COILS IN THE ANEURYSM, AND THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL IN QUESTION, IT STRETCHED WHICH MAY HAVE INADVERTENTLY CAUSED THE COIL TO BREAK. THEREFORE BASED ON ANALYSIS OF THE RETURNED DEVICE AND INFORMATION AVAILABLE, IT IS LIKELY THAT PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED.

    Description of Event or Problem · 1

    DURING PLACEMENT OF THE FINAL COIL IT STRETCHED AND BROKE. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER AS ONE FROM THE PATIENT. THE PHYSICIAN WAS SATISFIED WITH THE RESULTS AND THE PROCEDURE WAS COMPLETED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

    Description of Event or Problem · 1

    DURING PLACEMENT OF THE FINAL COIL IT STRETCHED AND BROKE. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER AS ONE FROM THE PATIENT. THE PHYSICIAN WAS SATISFIED WITH THE RESULTS AND THE PROCEDURE WAS COMPLETED. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0033432030 12766817

    Patients

    Seq Age Sex Outcome Treatment
    1 ECHELON MICROCATHETER (EV3)