BEUDAMED
    FDA Adverse Event Injury Summary report: N

    360 DEGREES GDC-18 COIL

    MDR report key: 1062723 · Received June 16, 2008

    Report

    Report Number
    2939204-2008-00230
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIV.
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC REQUESTED ADD'L INFO REGARDING THE ALLEGED EVENT. FROM THE RESPONSES IT WAS DETERMINED THAT THE COIL WAS INSPECTED BEFORE DEPLOYMENT AND NO ANOMALIES WERE NOTED. THE COIL SOAKED IN SALINE BEFORE USE. CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. NO ATTEMPTS HAD BEEN MADE TO DETACH THE COIL PRIOR TO IT DETACHING PREMATURELY. THE POWER SUPPLY AND CONNECTING CABLES WERE ALL USED CORRECTLY ACCORDING TO THE DIRECTIONS FOR USE (DFU). SEVEN OTHER COILS WERE SUCCESSFULLY DETACHED BEFORE THE SUBJECT DEVICE. NO FRICTION WAS EXPERIENCED AS THE COIL WAS ADVANCED THROUGH THE CATHETER. REPOSITIONING WAS CARRIED OUT IN A ONE-TO-ONE MOTION UNDER FLUOROSCOPY. THE PHYSICIAN INVOLUNTARILY PULLED A LITTLE STRONGLY DURING REPOSITIONING WHERE HE REPORTED HE FELT A LITTLE RESISTANCE. THE PT'S ANATOMY WAS OF AVERAGE TORTUOSITY. THE COIL DID DETACH INSIDE THE PT AND WAS SUCCESSFULLY RETRIEVED WITH A "MAMMARY CATHETER" AND OTHER TRANSEND GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) WHILE THE PHYSICIAN WAS TRYING TO REPOSITION THE COIL, "HE PULL STRONGLY AND THE COIL DETACHED FROM THE GUIDE". THIS COIL WAS THE LAST ONE USED IN THE PROCEDURE, AFTER 7 COILS. THE COIL WAS RETRIEVED WITH THE USE OF "MAMMARY CATHETER AND GUIDEWIRE". THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 360 DEGREES GDC-18 COIL (84 HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC, NEUROVASCULAR DIV. 3481830 11138200

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention TRANSEND GUIDEWIRES (2)| MAMMARY CATHETER (MFR UNK)| EXCELSION 1018