BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 968880 · Received December 21, 2007

    Report

    Report Number
    2024168-2007-00643
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 29, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORT STATUS: SERIOUS INJURY/SURGICAL INTERVENTION. REPORT RATIONALE: DISSECTION REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THROUGH THE RIGHT RADIAL ARTERY THE OSTIAL LM WAS ENGAGED USING ANOTHER COMPANY'S GUIDING CATHETER AND ANOTHER COMPANY'S SHEATH. AFTER CROSSING LCX LESION WITH A 0.014 BMW GUIDE WIRE AND ANOTHER COMPANY'S 2.5 X 20 MM BALLOON THE LESION WAS PRE-DILATED. ANGIOGRAM SHOWED DISSECTION OF MID PORTION OF LCX. IT COULD NOT BE DETERMINED WHICH DEVICE CAUSED THE DISSECTION. AN ATTEMPT WAS MADE TO IMPLANT A 3.0 X 28 MM XIENCE V AT PROXIMAL-MID PORTION, BUT THE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO VERY TORTUOUS SEGMENT. SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION WITH SIX DIFFERENT VISION STENTS, BUT NONE OF THESE CROSSED THE LESION, AS IT WAS A TORTUOUS SEGMENT. THE PROXIMAL SEGMENT OF THE LCX WAS THEN PRE-DILATED WITH THE SAME 2.5 X 20 MM BALLOON AT 12 ATM. USING THE BUDDY WIRE TECHNIQUE ANOTHER ATTEMPT WAS MADE TO CROSS THE LESION WITH A SHORT STENT, BUT THIS ALSO FAILED TO CROSS THE LESION. THE LESION WAS RE-DILATED USING THE SAME BALLOON AT 8 ATM FOR FIVE AND THREE MINUTES CAUSING A DISSECTION. AT THIS TIME, THE PATIENT DEVELOPED CONFUSION AND CHEST PAIN. THE PATIENT SYSTOLIC BLOOD PRESSURE DROPPED TO 50-60 MMHG. ANGIOGRAM SHOWED A PROPAGATED CLOT IN THE LAD WITH TIMI I FLOW OF BOTH LCX AND LAD ARTERIES. DILATION WAS PERFORMED AGAIN USING THE SAME BALLOON AT PROXIMAL PORTION RESULTING IN TIMI III FLOW. BLOOD PRESSURE WAS RESTORED, BUT THE LCX WAS CLOSED FROM PROXIMAL-MID PORTION. THE FINAL ANGIOGRAM SHOWED TIMI III FLOW IN LAD AND TIMI 0 FLOW IN LCX ARTERY. A DISSECTION OCCURRED IN THE PROXIMAL PORTION OF LCX. THE BMW, FLOPPY, AND WHISPER GUIDE WIRES WERE UNABLE TO CROSS THE LESION. DUE TO ONGOING CHEST PAIN WITH ACUTE LATERAL WALL MI, EMERGENCY CVT CONSULTATION WAS PERFORMED. AN EMERGENCY CORONARY GRAFT WAS PERFORMED WITHIN TWO HOURS AFTER THE COMPLICATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE 74DQX DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R| S FLOPPY II| 2.75 X 18| 2.5 X 12| 2.25X8| STENT: VISION 3.0 X 18| SHEATH: 6F| WHISPHER GUIDING CATHETER: EBU| 3.0 X 12| 3.0 X 12| GUIDE WIRE: BMW UNIVERSAL| DILATATION CATHETER: 2.5 X 20 SPRINTER| 2.25 X 12