BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE GUIDEWIRE

    MDR report key: 548082 · Received October 12, 2004

    Report

    Report Number
    6000123-2004-00087
    Event Type
    Malfunction
    Date Received
    October 12, 2004
    Date of Event
    September 12, 2004
    Report Date
    September 12, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP., BOSTON SCIENTIFIC
    Product Code
    MQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THE PHYSICIAN WAS PERFORMING A THERAPEUTIC PROCEDURE ON A PT. THE PHYSICIAN INTRODUCED THE GUIDEWIRE THROUGH THE CANNULA IN AN EFFORT TO ACCESS THE COMMON BILE DUCT (CBD). AFTER THE PHYSICIAN COMPLETED THE CHOLANGIOGRAM, THE WIRE WAS REMOVED. AT THAT TIME THE PHYSICIAN OBSERVED THAT A SMALL PART OF THE DEVICE'S TUNGSTEN COATING HAD PEELED OFF THE JAGWIRE'S TIP, AND REMAINED IN THE PT. THE PHYSICIAN THEN SUCCESSFULLY REMOVED THE COATING WITH THE AID OF A RETRIEVAL BALLOON. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE AFFECT TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE GUIDEWIRE GUIDEWIRE MQR BOSTON SCIENTIFIC CORP., BOSTON SCIENTIFIC NA 5242804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other