BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXFINDER GUIDEWIRE

    MDR report key: 91567 · Received May 13, 1997

    Report

    Report Number
    2183632-1997-00001
    Event Type
    Malfunction
    Date Received
    May 13, 1997
    Date of Event
    April 28, 1997
    Report Date
    May 12, 1997
    Manufacturer
    FLEXMEDICS CORP.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE DISTAL TIP BECAME "DISCONNECTED" FROM THE CORE WIRE BUT REMAINED ATTACHED. THE INCIDENT WAS REPORTED BY A MEDICAL DEVICE PRODUCT SALES AND DISTRIBUTION CO. THE PROCEDURE WAS SUCCESSFUL AND THE GUIDEWIRE WAS WITHDRAWN INTACT. THERE WAS NO INJURY TO THE PT. THE WIRE WAS RETURNED FOR FURTHER ANALYSIS OF THE FAILURE. GENERAL INFO WAS PROVIDED FOR REPORTING AND TO AID IN ANALYSIS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXFINDER GUIDEWIRE GASTROINTESTINAL GENITOURINARY GUIDEWIRE FGE FLEXMEDICS CORP. 101387 B1078

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ENDOCSCOPE (UNK BRAND)