BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XWIRE GUIDEWIRE

    MDR report key: 1902521 · Received November 11, 2010

    Report

    Report Number
    1320894-2010-00125
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 4, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED TO CONMED AND HAS NOT BEEN RECEIVED TO DATE. A SUPPLEMENTAL REPORT WILL BE FILED AFTER THE QUALITY ENGINEERING INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED: "PT WAS UNDERGOING AN ERCP, ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. USED 0.025 XWIRE FOR DIFFICULT CANNULATION, PROCEDURE LAST TWO HOURS. DR (B)(6) THOUGHT, HE HAD BEEN SUCCESSFUL BUT A PERFORATION WAS CONFIRMED WITH DYE AND X-RAY OF THE ABDOMEN SHOWED AIR IN THE CAVITY. NOTHING WAS NOTED ABOUT THE WIRE UNTIL IT WAS REMOVED, X-RAY CONFIRMED THAT A 1MM SECTION OF THE TIP WAS LEFT IN THE PT. VISUAL CHECK OF THE WIRE TIP SHOWED DAMAGE. PT UNAWARE OF THE INCIDENT. IT WAS REPORTED, PT INCURRED A LIFE-THREATENING INJURY REQUIRING ADMISSION. ALSO REPORTED THAT NO SURGICAL INTERVENTION HAS OCCURRED TO RETRIEVE THE WIRE TIP. PT'S STATUS REPORTED AS ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XWIRE GUIDEWIRE XWIRE DQX CONMED CORPORATION NA 0904201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| O