BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1900779 · Received November 16, 2010

    Report

    Report Number
    2939204-2010-01100
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    September 16, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE ALL MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON RELEASE. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. INFARCTION IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    AN MRI SCAN TAKEN THREE DAYS POST PROCEDURE REVEALED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE BASILAR TERRITORY, TREATED REGION. THE PHYSICIAN DOES NOT KNOW WHEN THIS ASYMPTOMATIC STROKE OCCURRED, IT MAY HAVE BEEN PRIOR TO THE PROCEDURE OR ASSOCIATED WITH THE PROCEDURE. THE PATIENT REMAINED ASYMPTOMATIC AND WAS DISCHARGED HOME WITH NO CLINICAL CONSEQUENCE.

    Description of Event or Problem · 1

    AN MRI SCAN TAKEN THREE DAYS POST PROCEDURE REVEALED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE BASILAR TERRITORY, TREATED REGION. THE PHYSICIAN DOES NOT KNOW WHEN THIS ASYMPTOMATIC STROKE OCCURRED, IT MAY HAVE BEEN PRIOR TO THE PROCEDURE OR ASSOCIATED WITH THE PROCEDURE. THE PATIENT REMAINED ASYMPTOMATIC AND WAS DISCHARGED HOME WITH NO CLINICAL CONSEQUENCE.

    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 - COSTA RICA M003468150 13414315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| WINGSPAN STENT (BOSTON SCIENTIFIC)