BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 6070412 · Received November 1, 2016

    Report

    Report Number
    2134265-2016-10024
    Event Type
    Death
    Date Received
    November 1, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED 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

    SAME CASE AS MDR: 2134265-2016-10389. IT WAS REPORTED THE PATIENT EXPERIENCED BRADY CARDIA AND EXPIRED. THE PHYSICIAN SELECTED THE USE OF A 1.5 ROTALINK PLUS FOR USE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ANGIOGRAPHY REVEALED THE LESION WAS TORTUOUS AND HAD DIFFUSE CALCIFICATION. THE LESION WAS CROSSED WITH A ROTA EXTRA SUPPORT GUIDEWIRE AND ABLATED WITH THE 1.5 ROTALINK PLUS. POST SUCCESSFUL ROTABLATION, THE PHYSICIAN WAS TRYING TO EXCHANGED THE ROTA WIRE WITH REGULAR PTCA WIRE, WHEN ALL OF THE SUDDEN, THE PATIENT DEVELOPED BRADY CARDIA AND WITHIN NO TIME, THERE WAS NO PULSE. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED AND THE PATIENT WAS INTUBATED BUT THE PATIENT EXPIRED. A DEATH CERTIFICATE WAS UNAVAILABLE BUT THE CAUSE OF DEATH IS BELIEVED TO BE BRADYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719730 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - MAPLE GROVE UNK376

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death