BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE GUIDEWIRE

    MDR report key: 1051767 · Received May 21, 2008

    Report

    Report Number
    3005099803-2008-00509
    Event Type
    Injury
    Date Received
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION IS NOT AVAILABLE, AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE APRIL 2008 15-MONTH JAGWIRE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN A FEMALE PATIENT IN 2005. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY ON APPROX TWO WEEKS LATER. AN ERCP IN JULY 2005 COULD NOT VISUALIZE THE BILIARY TRACT. THE PATIENT UNDERWENT SURGERY ON THE NEXT DAY. A LEFT VASCULOBILIARY INJURY (VBI) WAS DISCOVERED, AND THE PATIENT RECEIVED ABDOMINAL DRAINAGES. A SECOND ERCP ON SIX DAYS LATER REVEALED THAT FLOW THROUGH THE BILIARY VESSELS STOPPED NEAR THE CYSTIC DUCT. AT THAT POINT, CONTRAST MEDIUM FLOWED INTO THE ABDOMEN. IT WAS NOTED THAT THE JAGWIRE GUIDEWIRE USED DURING THIS PROCEDURE WENT ACROSS THE VESSEL AND INTO THE ABDOMEN. TWO HOURS LATER, COMPUTED TOMOGRAPHY (CT) REVEALED A HEMATOMA UNDER THE GLISSON'S CAPSULE AT HEPATIC SEGMENTS III-V. THE PHYSICIAN ALSO NOTED HEMOPERITONEUM. THE PATIENT UNDERWENT A RIGHT HEPATECTOMY IN TWO MONTHS LATER (DATE UNKNOWN). A CUT IN THE INTRAHEPATIC BRANCH OF THE RIGHT HEPATIC ARTERY WAS NOTED DURING THIS PROCEDURE. THE PATIENT'S CONDITION FOLLOWING THE SAME MONTH PROCEDURE WAS REPORTED AS "FINE." IT IS UNKNOWN IF THE JAGWIRE GUIDEWIRE CAUSED OR CONTRIBUTED TO THE HEMATOMA, HEMOPERITONEUM, OR HEPATIC ARTERY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION M0055660011 7796213

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R