BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4

    MDR report key: 1820142 · Received August 30, 2010

    Report

    Report Number
    2939204-2010-00914
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. VESSEL PERFORATION IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE STENT WAS SUCCESSFULLY PLACED ACROSS THE STENOTIC LESION INTO THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. HOWEVER, A VESSEL PERFORATION WAS NOTED AT THE MCA M2 SEGMENT. THE PHYSICIAN MANAGED TO STOP BLEEDING. THE EVENT CONSIDERED WAS RESOLVED WITH NO RESIDUAL EFFECT. THE PHYSICIAN STATED THAT THE VESSEL PERFORATION IS UNLIKELY RELATED TO THE BOSTON SCIENTIFIC DEVICES USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    THE STENT WAS SUCCESSFULLY PLACED ACROSS THE STENOTIC LESION INTO THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. HOWEVER, A VESSEL PERFORATION WAS NOTED AT THE MCA M2 SEGMENT. THE PHYSICIAN MANAGED TO STOP BLEEDING. THE EVENT CONSIDERED WAS RESOLVED WITH NO RESIDUAL EFFECT. THE PHYSICIAN STATED THAT THE VESSEL PERFORATION IS UNLIKELY RELATED TO THE BOSTON SCIENTIFIC DEVICES USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 4 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI M003468150 13082326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEUROFORM STENT SYSTEM (BOSTON SCIENTIFIC)