BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1021525 · Received March 26, 2008

    Report

    Report Number
    2024168-2008-00219
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 25, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST ON THE TIP COILS. A PORTION OF THE TIP COILS AND THE TIPBALL HAD SEPARATED AND WERE NOT RETURNED. THE TIP COILS WERE STRETCHED OUT AND HAD SEPARATED 2.1 CM DISTAL TO THE CENTER SOLDER. THE CORE WAS INTACT. THE SHAPING RIBBON WAS INTACT AND TWISTED FOR A LENGTH OF 3 CM DISTAL TO THE CENTER SOLDER. THE TACKING BETWEEN THE CORE AND SHAPING RIBBON HAD COME APART. THERE WAS A BEND IN THE CORE 5 MM DISTAL TO THE PROXIMAL SOLDER. 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 EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE FRAYED WHILE INSERTING IT INTO THE MID LEFT ANTERIOR DESCENDING ARTERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE. THIS IS BEING REPORTED BASED ON THE RETURNED PRODUCT EVALUATION WHICH REVEALED A GUIDE WIRE SEPARATION.

    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 7113094

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR