BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ EXTRA STIFF WIRE GUIDE

    MDR report key: 4020862 · Received August 1, 2014

    Report

    Report Number
    MW5037729
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 31, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A TUNNELED DIALYSIS CATHETER PLACED FOR ACUTE RENAL FAILURE. DURING INSERTION, THE GUIDE WIRE INADVERTENTLY PIERCED THE SUPERIOR VENA CAVA, PULMONARY ARTERY, AND LEFT ATRIUM. PATIENT HAD EMERGENCY HEART SURGERY TO REMOVE THE CATHETER AND REPAIR THE PERFORATIONS. THE PATIENT IS NOW IN THE ICU. FOLLOWING THE EVENT THE CATHETER WAS EXAMINED. THE GUIDE WIRE WAS FOUND TO BE BENT AT THE END IN A U SHAPE, WITH AN APPARENT FRACTURE OF THE WIRE ABOUT ONE INCH FROM THE TIP OF THE WIRE. PATIENT SAFETY ADVISES US THAT THE PUNCTURES COULD NOT HAVE BEEN CAUSED BY THE TIP OF THE GUIDE WIRE BECAUSE IT IS BLUNT. THE EXACT CAUSE IS UNKNOWN, BUT IT MAY BE THAT THE POINT AT WHICH THE GUIDE WIRE FRACTURED CREATED A SHARP POINT THAT MAY HAVE CAUSED THE PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451535 AMPLATZ EXTRA STIFF WIRE GUIDE CATHETER GUIDE WIRE KOG BOSTON SCIENTIFIC THSF-35-80-AES G04003

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening