BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1933465 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05548
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A VESSEL PERFORATION AND SUBSEQUENT DEATH OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. AFTER ADVANCING THE ROTAWIRE GUIDE WIRE AND 1.25MM ROTALINK BURR, ONE ABLATION RUN WAS SUCCESSFULLY COMPLETED AT 160,000 RPMS FOR 8 SECONDS. HOWEVER ON THE SECOND PASS A TOTAL PERFORATION OF THE MID LAD OCCURRED. NO DAMAGE WAS NOTED TO THE BURR, AND THERE WAS NO DIFFICULTY REMOVING THE BURR OR GUIDE WIRE. THE PATIENT EXPERIENCED CARDIAC ARREST AND CPR WAS PERFORMED WITH PERICARDIOCENTESIS AND UNSPECIFIED MEDICATIONS WERE GIVEN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR A THORACOTOMY, HOWEVER, THE PATIENT DIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680020

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death