BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 3061107 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02241
    Event Type
    Death
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROTABLATOR CATHETER UNIT WAS RETURNED. THE RELATED ROTAWIRE WAS RETURNED INSERTED IN THE CATHETER DEVICE. THE CATHETER COIL NEAR THE HANDSHAKE CONNECTION OF THE PLUS DEVICE WAS FOUND TO BE KINKED HOWEVER THE COIL WAS FOUND TO BE WITHIN SPECIFICATION ONCE THE GUIDEWIRE WAS REMOVED. THE KINKED COIL WAS A RESULT OF THE KINKED GUIDEWIRE. THE GUIDEWIRE WAS FOUND TO BE KINKED IN A NUMBER OF LOCATIONS. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE BURR AND SENT FOR ANALYSIS. THE BURR WAS MICROSCOPICALLY EXAMINED. THE ANNULUS WAS FOUND TO BE MISSHAPEN/DAMAGED. 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

    SAME CASE AS MR ID 2134265-2013-02435. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER SOME BURR ROTATION, THE ROTAWIRE BROKE AND CAUSED A CORONARY PERFORATION WHICH REQUIRED PERICARDIAL DRAINS. THE PATIENT FIBRILLATED AND DIED. THE BROKEN PART OF THE ROTAWIRE IS STILL INSIDE THE PATIENT. THE CAUSE OF THE DEATH IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162290 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 15193240

    Patients

    Seq Age Sex Outcome Treatment
    1 Death