BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE TRAVERSE GUIDE WIRE

    MDR report key: 1060462 · Received June 13, 2008

    Report

    Report Number
    2024168-2008-00489
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K984394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING COULD NOT COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THE CORE AND TIP COILS WERE DETACHED 5 MM DISTAL TO THE CENTER SOLDER AND NOT RETURNED. THERE WAS CORROSION PRESENT ON THE CENTER SOLDER. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THIS HAS BEEN SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING COULD NOT COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - PERMANENT DAMAGE. REPORTING RATIONALE: SEPARATED GUIDE WIRE REMAINS IN THE PT. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE TRAVERSE GUIDE WIRE HAD SEPARATED AND REMAINS INSIDE THE PT'S BODY. IT WAS NOTED THAT THE GUIDE WIRE WAS HEAVILY TORQUED, WHICH MAY HAVE LED TO THE SEPARATION. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE TRAVERSE GUIDE WIRE 74DQX DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8031491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability