BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1841733 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04412
    Event Type
    Death
    Date Received
    September 22, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2010-04382, 2134265-2010-04390. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, A BURR BECAME STUCK IN THE LESION. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. ACCESS WAS GAINED FROM THE RIGHT FEMORAL ARTERY, AND THE ROTAWIRE FLOPPY GUIDE WIRE WAS ADVANCED. THE PHYSICIAN COMPLETED ONE ABLATION RUN WITH THE 1.25MM ROTALINK PLUS BURR, AND THE BURR WENT COMPLETELY THROUGH THE LESION. THE PHYSICIAN THEN EXCHANGED THE BURR FOR THE 1.5MM, CONNECTING AND TESTING THE SYSTEM. THE PHYSICIAN ADVANCED THE 1.5MM BURR, HOWEVER AFTER ABOUT 7 SECONDS THE BURR DECELERATED AND STALLED IN THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE BURR USING THE DYNAGLIDE MODE AND MANUAL REMOVAL WITHOUT SUCCESS. THE PHYSICIAN ALSO ADVANCED 2 NON BSC GUIDE WIRES AND ADVANCED A 2.0 X 12MM APEX BALLOON, INFLATING IT TO 6 ATMS IN AN ATTEMPT TO LOOSEN AND REMOVE THE BURR WITHOUT SUCCESS. THE PHYSICIAN ATTEMPTED TO GAIN ACCESS FROM THE LEFT GROIN, ADVANCING ANOTHER NON BSC GUIDE WIRE AND ANOTHER 2.0 X 12MM APEX BALLOON PAST THE BURR, HOWEVER THEY WERE STILL UNSUCCESSFUL IN REMOVING THE BURR. THE PHYSICIAN THEN INFLATED A 2.5 X 12MM APEX BALLOON DISTAL TO THE BURR IN AN ATTEMPT TO USE IT TO PULL BACK THE BURR, HOWEVER THE BURR WOULD NOT DISLODGE. THE PATIENT WAS TAKEN TO SURGERY, AND THE BURR WAS REMOVED WITH "MUCH DIFFICULTY". THE PATIENT WAS TAKEN TO THE CVICU, AND SUBSEQUENTLY DIED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE GREATER THAN 25MM LONG LESION WAS APPROXIMATELY 90% STENOSED, AND THE MILDLY TORTUOUS VESSEL WAS MODERATELY CALCIFIED. THE 1.25MM BURR WAS RUN AT 160,000 RPMS FOR APPROXIMATELY 20-25 SECONDS. THE 1.5MM BURR WAS ALSO RUN AT 160,000 RPMS UNTIL IT DECELERATED AND STALLED. CONTINUOUS SALINE FLUSH HAD BEEN MAINTAINED THROUGHOUT THE PROCEDURE. THE BURR WAS REMOVED DURING SURGERY, AND BYPASS WAS PERFORMED. THE PATIENT DIED SEVERAL HOURS FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 13464362

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death FLOPPY ROTAWIRE GUIDE WIRE| ROTALINK BURR 1.5MM