BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDE

    MDR report key: 1081488 · Received July 23, 2008

    Report

    Report Number
    2024168-2008-00595
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - QUALITY ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE CORE AND COILS. THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS APPROX .5MM OF CORE EXTENDING FROM THE DISTAL END OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. QUALITY ENGINEERING WAS UNABLE TO PERFORM AN EVAL AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SEROUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: SEPARATED GUIDE WIRE REQUIRING MEDICAL INTERVENTION (SNARING). DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE SNAPPED IN HALF DURING USE. THE SEPARATED GUIDE WIRE HAD TO BE REMOVED WITH THE USE OF A SNARE DEVICE. ADD'L INFO REPORTED THAT THE GUIDE WIRE WAS BEING USED IN A PERIPHERAL CASE AND WAS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO BALLOON CATHETER ADVANCED OVER THE GUIDE WIRE AND IT WAS BEING USED WITH A CROSSOVER SHEATH. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8032681

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention GUIDING CATHETER: CROSS OVER