BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3222299 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04918
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    March 18, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE ROTABLATOR PLUS UNIT RETURNED CONNECTED TOGETHER. A VISUAL EXAMINATION OF THE COMPLAINT PLUS UNIT WAS CARRIED OUT. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. A CONNECT/DISCONNECT TEST WAS CARRIED OUT. NO ISSUES WERE NOTED WITH THE UNIT¿S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. THE ROTABLATOR UNIT WAS WIRE GUIDED USING A CONTROL GUIDE WIRE. NO ISSUES WERE NOTED DURING THE WIRE GUIDING OF THE DEVICE. AN ATTEMPT WAS MADE TO WET TEST THE PLUS UNIT. THE DEVICE WAS CONNECTED TO THE ROTABLATOR CONSOLE AND THE SALINE INFUSION WAS TURNED ON. THE DEVICE WAS FOUND TO BE LEAKING FROM THE CATHETER SHEATH UNDER THE STRAIN RELIEF. ON FURTHER INSPECTION A TEAR/DAMAGE WAS CONFIRMED IN THE CATHETER SHEATH UNDER THE STRAIN RELIEF. THE ROTABLATOR PLUS WAS WET TESTED AND NO SPEED WAS ACHIEVED. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(4) 2013. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO BE ADVANCED TO THE LESION. THE 99% STENOSED TARGET LESIONS WERE LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED 1ST DIAGONAL (DIAG) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE PHYSICIAN INITIALLY ADVANCED THE 1.5MM ROTALINK PLUS AND ROTAWIRE TO THE 1ST DIAG. THEN PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICES TO THE LAD; HOWEVER, THE PHYSICIAN COULD NOT ADVANCE THE ROTALINK PLUS TO THE LAD AS IT SEEMED 'INCOMPATIBLE' WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME ROTALINK PLUS. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SALINE LEAK IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324571 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15739655

    Patients

    Seq Age Sex Outcome Treatment
    1