BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHOLEY HI-TORQUE MODIFIED J GUIDE WIRE

    MDR report key: 1241722 · Received November 20, 2008

    Report

    Report Number
    2024168-2008-01193
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    June 6, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K861765
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED GUIDE WIRE REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: SEPARATED GUIDE WIRE. IT WAS REPORTED THAT THE PROCEDURE INVOLVED AN ATTEMPT TO ENTER THE PERICARDIUM (CONFIRMED WITH A SMALL INJECTION OF CONTRAST). A .035 EXTRA-STIFF GUIDE WIRE COULD NOT BE SATISFACTORILY ADVANCED, SO IT WAS DECIDED TO USE A WHOLEY .035 GUIDE WIRE. THIS INITIALLY ADVANCED INTO THE PERICARDIAL SPACE, BUT WAS 'BACKED OUT' BETWEEN THE DIAPHRAGM AND THE PERICARDIUM. THE NEEDLE WAS WITHDRAWN. AT THIS STAGE, AN ATTEMPT TO WITHDRAW THE GUIDE WIRE WAS UNSUCCESSFUL. A 5 FR DILATOR WAS ADVANCED OVER THE GUIDE WIRE TO THE LEVEL OF THE DIAPHRAGM (TO STRAIGHTEN OUT THE GUIDE WIRE) AND AN ATTEMPT TO WITHDRAW INTO THE DILATOR RESULTED IN THE GUIDE WIRE FRACTURING, AND THE DISTAL END REMAINING AT THE POSITION AT THE DIAPHRAGM. THE PATIENT REQUIRED A SECOND VISIT FOR SURGERY TO REMOVE SEPARATED GUIDE WIRE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHOLEY HI-TORQUE MODIFIED J GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8032892

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R| S