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: 2011873 · Received March 9, 2011

    Report

    Report Number
    2939204-2011-00101
    Event Type
    Injury
    Date Received
    March 9, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ANEURYSM RUPTURE AND NEUROLOGICAL DEFICIT ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE PATIENT UNDERWENT THE PROCEDURE ON (B)(6) 2006, THE EXACT DATE IS UNKNOWN. THE EVENT WAS REPORTED BY THE LAWYER, MR. (B)(6). NO CONTACT DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANEURYSM RUPTURED DURING THE EMBOLIZATION. THE PATIENT HAD SUBSEQUENT 'DYSFUNCTIONS OF UPPER/LOWER EXTREMITIES'. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANEURYSM RUPTURED DURING THE EMBOLIZATION. THE PATIENT HAD SUBSEQUENT 'DYSFUNCTIONS OF UPPER/LOWER EXTREMITIES'. NO FURTHER INFORMATION WAS PROVIDED.

    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 M003347715SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S SENTRY BALLOON CATHETER (BOSTON SCIENTIFIC)| TRANSEND EX 014 GUIDEWIRE (BOSTON SCIENTIFIC)| MODEL-TRANSEND .010 GUIDEWIRE (BOSTON SCIENTIFIC)| GUIDER CATHETER (BOSTON SCIENTIFIC)| EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)