BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS 0.014" X 190CM GUIDE WIRE

    MDR report key: 3231300 · Received July 11, 2013

    Report

    Report Number
    MW5030897
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ABBOT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD, FEMALE, ADMITTED THROUGH THE EMERGENCY ROOM AS CODE H STEMI WITH CHEST PAIN AND ANTEROLATERAL ST ELEVATION. THE PT WAS TAKEN URGENTLY TO THE CATH LAB FOR INTERVENTION. A 95 PERCENT MID-DISTAL LAD LESION WITH TIMI II FLOW WAS PRESENT. AFTER A BMW WIRE COULD NOT NEGOTIATE THE TORTUOUS LAD, A WHISPER WIRE WAS STEERED THROUGH THE LESION INTO THE VERY DISTAL LAD. BALLOON ANGIOPLASTY WAS PERFORMED OVER THE WHISPER WIRE WITH A 2.5 X 12 MM MAVERICK RX BALLOON WITH 2 INFLATIONS AT 6 ATM. FOLLOWING REMOVAL OF THE BALLOON, ATTEMPTS TO BRING A STENT OVER THE WHISPER WIRE TO THE LESION WERE UNSUCCESSFUL. THE STENT WAS UNABLE TO PASS THROUGH THE MORE PROXIMAL LAD TORTUOSITY. A RUNTHROUGH WIRE WAS THEN STEERED TO THE DISTAL LAD TO SERVE AS A BUDDY WIRE. ATTEMPTS TO BRING A STENT OVER THE WHISPER WIRE TO THE DISTAL LAD WERE AGAIN UNSUCCESSFUL. A STENT WAS THEN POSITIONED IN THE DISTAL LAD OVER THE RUNTHROUGH WIRE. FOLLOWING THIS IT WAS REALIZED THAT THE WHISPER WIRE HAD FRACTURED. THE PROXIMAL PORTION OF THE WHISPER WIRE WAS REMOVED. THE STENT WAS REMOVED OVER THE RUNTHROUGH WIRE. ALL ATTEMPTS TO RETRIEVE THE DISTAL PORTION OF THE FRACTURED WHISPER WIRE WERE UNSUCCESSFUL, AND AT THE CONCLUSION OF THE PROCEDURE THE DISTAL PORTION OF THE WHISPER WIRE REMAINED IN THE DISTAL LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319758 HI-TORQUE WHISPER MS 0.014" X 190CM GUIDE WIRE ARTHERECTOMY STENT GUIDEWIRE DQX ABBOT VASCULAR REF 1005357 3020371

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization