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: 2122263 · Received June 13, 2011

    Report

    Report Number
    2939204-2011-00333
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT CONTINUOUS FLUSH WAS MAINTAINED, THE ANATOMY WAS MODERATELY TORTUOUS AND NO RESISTANCE WAS ENCOUNTERED PRIOR TO THE COIL STRETCHING.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT IS MOST LIKELY THAT OPERATIONAL CONTEXT WAS THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    TWO COILS HAD BEEN SUCCESSFULLY IMPLANTED INTO THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. AS THE PHYSICIAN WAS REPOSITIONING THE DEVICE, THE COIL STRETCHED. THE PHYSICIAN WAS UNABLE TO WITHDRAW THE COIL INTO THE MICROCATHETER AND HAD TO DETACH THE COIL WITH A PORTION PROTRUDING INTO THE PARENT VESSEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE COIL WITH A SNARE DEVICE AND APPROXIMATELY 4CM OF THE STRETCHED COIL REMAINS PROTRUDING INTO THE PARENT VESSEL. ANGIOGRAPHY DEMONSTRATED THAT THE PROTRUDING COIL DID NOT AFFECT THE VESSEL AND THE ANEURYSM COILING THERAPEUTIC EFFECT WAS ACHIEVED. THE PHYSICIAN TOOK NO FURTHER ACTION REGARDING THE PROTRUDING COIL AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    TWO COILS HAD BEEN SUCCESSFULLY IMPLANTED INTO THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. AS THE PHYSICIAN WAS REPOSITIONING THE DEVICE, THE COIL STRETCHED. THE PHYSICIAN WAS UNABLE TO WITHDRAW THE COIL INTO THE MICROCATHETER AND HAD TO DETACH THE COIL WITH A PORTION PROTRUDING INTO THE PARENT VESSEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE COIL WITH A SNARE DEVICE AND APPROXIMATELY 4CM OF THE STRETCHED COIL REMAINS PROTRUDING INTO THE PARENT VESSEL. ANGIOGRAPHY DEMONSTRATED THAT THE PROTRUDING COIL DID NOT AFFECT THE VESSEL AND THE ANEURYSM COILING THERAPEUTIC EFFECT WAS ACHIEVED. THE PHYSICIAN TOOK NO FURTHER ACTION REGARDING THE PROTRUDING COIL AND THERE WAS NO CLINICAL CONSEQUENCE 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 M003347204SR0 0013977518

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention GDC COIL (BOSTON SCIENTIFIC)| EV3 COIL (MODEL UNKNOWN)| EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC)