BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDRA-JAGWIRE

    MDR report key: 855074 · Received May 24, 2007

    Report

    Report Number
    6000123-2007-00022
    Event Type
    Death
    Date Received
    May 24, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 2, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDE
    PMA / PMN Number
    K942677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. RESULTS OF THE DEVICE EVALUATION, DEVICE HISTORY RECORD REVIEW AND PRODUCT FAMILY COMPLAINT TREND REVIEW WILL BE PROVIDED IN A F/U MEDWATCH REPORT.

    Description of Event or Problem · 1

    IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. THAT WHILE USING A HYDRA JAGWIRE DURING STENT PLACEMENT, ON A FEMALE PT, THE "DISTAL TIP OF THE DEVICE HAS BEEN LOST IN PT". THE PHYSICIAN REMOVED THE HYDROPHILIC TIP AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ANOTHER DEVICE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRA-JAGWIRE FDE BOSTON SCIENTIFIC M00556061 9540519

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR