BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGUIDE GUIDE WIRE

    MDR report key: 178568 · Received July 23, 1998

    Report

    Report Number
    6000039-1998-00012
    Event Type
    Injury
    Date Received
    July 23, 1998
    Report Date
    June 25, 1998
    Manufacturer
    MEDI-TECH
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A PORTION OF THE COATING FROM THE DISTAL TIP OF THIS GUIDE WIRE DETACHED IN THE PT WHEN BEING USED THROUGH A SOFT PIG TAIL CATHETER DURING AN ANGIOGRAM PROCEDURE. RETRIEVAL WITH A SNARE WAS UNEVENTFUL. NO PT COMPLICATIONS RESULTED FROM THIS EVENT. THIS DEVICE HAS NOT BEEN REC'D FOR EVAL. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. CO'S ATTEMPTS TO GAIN FURTHER DETAILS REGARDING THE CIRCUMSTANCES OF THIS EVENT HAVE BEEN UNSUCCESSFUL. WITHOUT EVALUATING THIS DEVICE AND WITHOUT FURTHER DETAILS REGARDING THE CIRCUMSTANCES OF THIS EVENT, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. SAME CASE AS MFR REPORT 6000039-1998-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGUIDE GUIDE WIRE GUIDEWIRE DQX MEDI-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention