BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACER METRO WIRE GU

    MDR report key: 517334 · Received March 23, 2004

    Report

    Report Number
    1037905-2004-00056
    Event Type
    Injury
    Date Received
    March 23, 2004
    Date of Event
    December 5, 2003
    Report Date
    February 23, 2004
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SUFFERING FROM CHRONIC PANCREATITIS WITH BLOCKAGES. DURING A STENTING PROCEDURE THE PHYSICIAN USED A WILSON-COOK TRACER METRO WIRE GUIDE TO PLACE A ZIMMON PANCREATIC STENT IN THE PATIENT'S DUCT. DURING THE STENTING PROCEDURE THE PHYSICIAN ADVANCED THE WIRE GUIDE INTO THE PANCREAS, INADVERTANTLY PERFORATED THE PANCREATIC DUCT. THIS RESULTED IN THE FORMATION OF A CYST AND ACUTE PANCREATITIS. THE STENT WAS SUCCESSFULLY PLACED AND THE PATIENT UNDERWENT FOLLOW-UP TREATMENT TO CLEAR UP THE PANCREATITIS AND TO DISSIPATE THE CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACER METRO WIRE GU COATED WIRE GUIDES DQX WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization