BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTALINK¿ BURR

    MDR report key: 3033579 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-01958
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 TREATMENT PROCEDURE, A DEVICE ENTRAPMENT OCCURRED. THE 95% IN-STENT RESTENOSIS WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE 1.50MM ROTALINK BURR WAS ENTRAPPED IN THE LESION. WHILE ATTEMPTING TO REMOVE THE ENTRAPPED DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY AND WAS UNABLE TO REMOVE THE DEVICE. BYPASS SURGERY WAS SUCCESSFULLY PERFORMED. LATER, THE PATIENT DEVELOPED ADDITIONAL BLEEDING COMPLICATIONS. THE PATIENT WAS "REOPENED TO CLOSE THE BLEED". THE PATIENT EXPIRED FOUR DAYS FOLLOWING THE SURGERY. THE CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136977 ROTALINK¿ BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 15495623

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R CORDIS 6F SHEATH| 6F CLS 3.5 GUIDE