BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYI

    MDR report key: 1057008 · Received June 5, 2008

    Report

    Report Number
    2024168-2008-00457
    Event Type
    Malfunction
    Date Received
    June 5, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THE SHAPING RIBBON WAS DETACHED FROM THE TIPBALL. THE CORE AND COILS WERE STILL INTACT. THERE WERE SEVERAL OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 3 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRONIC MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PROD PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE TIP SEPARATION. DEVICE ISSUE: GUIDE WIRE TIP SEPARATION. IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS BEING PULLED BACK TO EXCHANGE IT, THE GUIDE WIRE WAS FOUND TO BE STRETCHED DISTALLY AT THE COILS, AND THE SHAPING RIBBON WAS SEPARATED FROM THE TIPBALL. NO PT EFFECTS WERE REPORTED. 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 HYI DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8030881

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK