BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTALINK? BURR

    MDR report key: 3951127 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04503
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE BURR GOT STUCK IN THE LESION AND THE PATIENT CODED, PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT EXPIRED. THE 90% CALCIFIC LESION AS LOCATED INBETWEEN TWO UNSPECIFIED STENTS IN THE LEFT ANTERIOR DESCENDING (LAD) THE PROXIMAL LAD. THE PHYSICIAN WENT IN WITH A 1.75MM ROTABLATOR BURR AND WAS ABLE TO ABLATE THE LESION ONCE. ANOTHER ATTEMPT WAS BEING MADE WHEN THE BURR STALLED AND GOT STUCK. THE GUIDE CATHETER WAS ADVANCED FURTHER INTO THE LESION AND THE BURR, THE GUIDE WIRE, AND THE GUIDE CATHETER WERE ABLE TO BE REMOVED ALL TOGETHER. THE PHYSICIAN WAS ABLE TO DOING SOME BALLOONING AND IT LOOKED LIKE THEY HAD FLOW. THE PHYSICIAN COMPLETED THE PROCEDURE AND CLOSURE ACTIVITIES WERE BEING PERFORMED WHEN THE PATIENT CODED. THE PHYSICIAN WAS CALLED BACK IN AND THOUGHT THE PATIENT MIGHT HAVE A BLEED INTO THE PERICARDIUM, SO A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN WAS ABLE TO REMOVE SOME FLUID BUT THE PATIENT WAS NOT ABLE TO RECOVER AND EXPIRED. IT WAS NOTED "THE PHYSICIAN MENTIONED THAT IT WASN'T THE ROTABLATOR, THE ROTABLATOR WORKED FINE, IT WAS JUST A VERY DIFFICULT CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427690 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680040

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R