BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3864185 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03800
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID 2134265-2014-03799. (B)(4). IT WAS REPORTED THAT CHEST PAIN AND CARDIAC ARREST OCCURRED. THE PATIENT WAS TO HAVE UNDERGONE PCI WITH THE USE OF A ROTABLATOR ATHERECTOMY DEVICE. THE PROCEDURE WAS COMMENCED, AND THE CORONARY ARTERY WAS BEING MANIPULATED. PRIOR TO HOOKING THE ROTABLATOR ATHERECTOMY DEVICE TO THE PATIENT, IT WAS NOTED THAT THE DEVICE WAS NOT WORKING. THE PATIENT HAD CHEST PAIN AND WAS UNSTABLE. CARDIAC SURGERY WAS PAGED AND ARRIVED. THE PATIENT WENT INTO CARDIAC ARREST, AND A FULL CODE WAS CALLED. THE PATIENT WAS PLACED ON ECMO AND UNDERWENT AN EMERGENCY CABG X3. SHORTLY THEREAFTER, THE PATIENT RETURNED TO THE OPERATING ROOM RE: BLEEDING PATIENT IN CSICU IN CRITICAL CONDITION. A ROTAWIRE WAS ALSO NOTED TO HAVE BEEN USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338476 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROTABLATOR CONSOLE