BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2982571 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01169
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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). A TUG AND CONNECT/DISCONNECT TEST WERE PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION AND NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT WAS MADE TO WIRE GUIDE THE BURR UNIT USING A TEST GUIDEWIRE BUT RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. MICROSCOPIC EXAMINATION OF THE BURR REVEALED THAT THE BURR ANNULUS WAS MIS-SHAPEN. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. A SCRATCH TEST WAS PERFORMED TO CONFIRM IF THE RETURNED BURRS CUTTING ACTION WAS ACCEPTABLE. THE DIAMOND PLATED AREA OF THE BURR WAS SCRATCHED ALONG THE SIDE OF A SINGLE EDGE BLADE. WHEN THE SIDE OF THE BLADE WAS VISUALLY EXAMINED, A SCRATCH MARK FROM WHERE THE BURR CAME INTO CONTACT WITH THE SIDE OF THE BLADE WAS NOTED CONFIRMING THAT THE BURRS CUTTING ACTION WAS ACCEPTABLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USE RELATED ISSUES. THE ROOT CAUSE OF THE REPORTED COMPLAINT HAS BEEN DETERMINED TO BE USER RELATED AS PER THE DFU: "NEVER ADVANCE THE ROTATING BURR TO THE POINT OF CONTACT WITH THE GUIDEWIRE SPRING TIP. SUCH CONTACT COULD RESULT IN DISTAL DETACHMENT AND EMBOLIZATION OF THE TIP." (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-01062. IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, GUIDE WIRE FRACTURE OCCURRED. DURING PREPARATION, WHILE OUTSIDE THE PATIENT BODY, THE PHYSICIAN USED AN UNSPECIFIED ROTAWIRE GUIDE WIRE WITH THE 1.50MM ROTABLATOR ROTALINK DEVICE BUT THE GUIDE WIRE SEPARATED APPROXIMATELY 10 TO 15 CM FROM THE PROXIMAL END OF THE ADVANCER. ANOTHER OF THE SAME ROTAWIRE GUIDE WIRE DEVICE WAS ADVANCED BUT RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE USING ANOTHER OF THE SAME GUIDE WIRE WITH THE SAME ROTABLATOR ROTALINK DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89042 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0015536622

    Patients

    Seq Age Sex Outcome Treatment
    1