BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 6073621 · Received November 2, 2016

    Report

    Report Number
    2134265-2016-09973
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 5, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-09559. IT WAS REPORTED THAT VESSEL PERFORATION AND PATIENT DEATH OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTALINK PLUS AND A ROTAWIRE WERE USED TO ADVANCE AND TREAT THE TARGET LESION. A 330CM ROTAWIRE WAS USED TO ADVANCE TO THE TARGET LESION. DURING THE PROCEDURE, DIFFICULTY IN CROSSING THE LESION WAS ENCOUNTERED AND IT WAS NOTED THAT THE COIL PART OF THE WIRE WAS STRETCHED. THE WIRE WAS EXCHANGED WITH ANOTHER ROTAWIRE AND PERFORMED ABLATION FOR THREE TIMES AT 180,000RPM FOR ABOUT 60 SECONDS EACH. DURING THE THIRD ABLATION, IT WAS NOTED THAT THE CORONARY ARTERY WAS PERFORATED. AFTER THE PERFORATION, A NON BSC STENT WAS PLACED. HOWEVER, PERFORATION OCCURRED IN THE DISTAL OF THE STENT. THEN, A NON BSC BALLOON WAS USED IN ATTEMPT TO STOP THE BLEEDING. THEN, A SECOND STENT WAS PLACED IN FRONT OF THE FIRST STENT, BUT PERFORATION ALSO OCCURRED IN THE PROXIMAL OF THE SECOND STENT. THE PHYSICIAN ATTEMPTED TO STOP THE BLEEDING IN LAD AND COMPLETED THE PROCEDURE INSUFFICIENT. THE PROCEDURE TIME WAS 8 HOURS. AN INTRA-AORTIC BALLOON PUMP (IABP) AND PERCUTANEOUS CARDIOPULMONARY SYSTEMS (PCPS) WERE INSERTED TO THE PATIENT AND WAS MONITORED. THEN, THE PATIENT WAS PREPARED FOR TRANSFER TO ANOTHER FACILITY OF CARDIAC SURGERY. THE PATIENT DIED BEFORE THE TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724459 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death