BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISPER GUIDE WIRE

    MDR report key: 857090 · Received May 18, 2007

    Report

    Report Number
    2124215-2007-99584
    Event Type
    Injury
    Date Received
    May 18, 2007
    Date of Event
    April 27, 2007
    Report Date
    May 18, 2007
    Manufacturer
    *
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION: THIS EVENT ORIGINATED WITH ABBOTT VASCULAR CARDIAC THERAPIES, WHO REPORTED THE GUIDE WIRE WAS NOT AVAILABLE FOR RETURN FROM THE REPORTING HOSP AT THE TIME THE MEDWATCH REPORT WAS RECEIVED. THIS EVENT WILL BE REOPENED AND UPDATED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: BOSTON SCIENTIFIC RECEIVED INFO THAT THE END OF THIS GUIDEWIRE BROKE OFF IN THE CORONARY SINUS OF THE PT. THE PHYSICIAN DETERMINED THAT IT WAS BEST TO LEAVE THE WIRE FRAGMENT WITHIN THE PT. THE LENGTH OF THE WIRE WAS TWO INCHES. THE PT WAS STABLE UPON DISCHARGE. NO ADD'L INFO WAS AVAILABLE. THE GUIDEWIRE COULD NOT BE IDENTIFIED BEYOND THE MODEL NUMBER AND THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHISPER GUIDE WIRE GUIDE WIRE DQX * 4586 6071751

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention