BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC

    MDR report key: 1060945 · Received June 13, 2008

    Report

    Report Number
    2024168-2008-00486
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CORE AND COILS. THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THE COILS WERE IN A CORKSCREW SHAPE. THERE WAS CORROSION PRESENT ON THE CENTER SOLDER. THERE WERE SEVERAL OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 8 MM. THERE WAS A KINK IN THE CORE 3.2 CM PROXIMAL TO THE TIPBALL. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE USED IVUS WAS NOT RETURNED. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. 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.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE PROCEDURE INVOLVED A LESION AT THE BIFURCATION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE FIRST DIAGONAL, AND THE VESSEL DIAMETER WAS 3.0 MM. THE BALANCE GUIDE WIRE WAS ENGAGED IN THE LAD AND A BMW GUIDE WIRE WAS IN THE FIRST DIAGONAL. PRE-DILATATION WAS PERFORMED WITH ANOTHER CO'S BALLOON AND ANOTHER CO'S STENT WAS DEPLOYED SUCCESSFULLY. THEN IVUS (INTRAFOCUS/TERUMO) WAS PERFORMED WITH THE BALANCE GUIDE WIRE. AFTER IT WAS FINISHED, DURING THE REMOVAL OF THE IVUS, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. THE DEVICES WERE PULLED AND WERE REMOVED OUT OF THE PT. WHILE CHECKING THE DEVICES IN VITRO, IT WAS FOUND THAT THE BALANCE GUIDE WIRE HAD SEPARATED INTO TWO PIECES. THE SEPARATION WAS OBSERVED AT THE HYPOTUBE. NONE OF THE PIECES REMAINED IN THE PT. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7050871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OTHER: INTRAFOCUS/TERUMO| DIL CATH: IKAZUCHI 2.5 X 15| STENT: TAXUS 3.0 X 20