BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1934803 · Received December 21, 2010

    Report

    Report Number
    2939204-2010-01155
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF AT THE USER FACILITY. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THE DEVICE WAS USED AGAINST THE INSTRUCTIONS FOR USE AND IT IS PROBABLE THAT PROCEDURAL FACTORS LEAD TO THE DIFFICULTIES EXPERIENCED IN DETACHING THE COIL. WHICH IN TURN MAY HAVE LEAD TO THE COIL PROTRUSION AS THE COIL MOVED OUT OF PLACE DURING THE ATTEMPTS TO DETACH THE COIL. THEREFORE, BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    DURING PROCEDURE THE COIL WAS INSERTED INTO THE ANEURYSM. THE POWER SUPPLY SIGNALED COIL DETACHMENT, HOWEVER, AS THE PHYSICIAN MOVED THE PUSHERWIRE HE NOTED THE COIL WAS STILL ATTACHED AND A PORTION OF THE COIL PROTRUDED OUTSIDE THE ANEURYSM. THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PATIENT. HOWEVER, AS THE COIL WAS RETRACTED INTO THE MICROCATHER IT SUDDENLY DETACHED. THE COIL WAS RETRIEVED WITH A SNARE AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS INJURY BUT HAD "LITTLE MOTORICAL PROBLEMS" THAT THE PHYSICIAN EXPECTED TO FULLY RESOLVE.

    Description of Event or Problem · 1

    DURING PROCEDURE THE COIL WAS INSERTED INTO THE ANEURYSM. THE POWER SUPPLY SIGNALED COIL DETACHMENT, HOWEVER AS THE PHYSICIAN MOVED THE PUSHERWIRE HE NOTED THE COIL WAS STILL ATTACHED AND A PORTION OF THE COIL PROTRUDED OUTSIDE THE ANEURYSM. THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PATIENT. HOWEVER, AS THE COIL WAS RETRACTED INTO THE MICROCATHETER IT SUDDENLY DETACHED. THE COIL WAS RETRIEVED WITH A SNARE AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. IT WAS REPORTED THAT THE PATIENT WAS STABLE BUT HAD MINOR MOTORICAL PROBLEMS THAT THE PHYSICIAN EXPECTED TO FULLY RESOLVE.

    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 M003346509SR0 0013642229

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention POWER SUPPLY (MODEL AND MANUFACTURER UNKNOWN)| EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)