BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1071785 · Received July 7, 2008

    Report

    Report Number
    2024168-2008-00552
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FOR THE GUIDE WIRE TO FAIL DUE TO TORSIONAL OVERLOAD, SOME PORTION OF THE WIRE WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR IN ANOTHER DEVICE AND EXCESS TORQUE APPLIED. FROM THE INCIDENT DESCRIPTION, THE TIP OF THE GUIDE WIRE BECAME TRAPPED AND STUCK IN THE VESSEL. THE GUIDE WIRE MAY HAVE BEEN TORQUED AFTER IT WAS TRAPPED IN THE VESSEL AND FORCE WAS USED TO FREE THE GUIDE WIRE AS REPORTED IN THE CASE DESCRIPTION. WITHOUT THE DEVICE TO EXAMINE, A THOROUGH ANALYSIS CANNOT BE PERFORMED, AND NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED DISCREPANCY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE CORE SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE CORE SEPARATION. IT WAS REPORTED THAT THE BMW UNIVERSAL GUIDE WIRE WAS EASILY POSITIONED IN THE DISTAL PORTION OF THE VESSEL. AFTER STENTING THE LESION, AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE, BUT THE DISTAL PORTION STRETCHED FOR ABOUT 4 CM AND COULD NOT BE REMOVED. BY ADVANCING THE GUIDE CATHETER DEEPER AND USING FORCE, THE GUIDE WIRE WAS ABLE TO BE REMOVED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8031891

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK