BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? BURR

    MDR report key: 3964523 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04504
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    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

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A ROTATIONAL ATHERECTOMY PROCEDURE, UNSTABLE SPEED OCCURRED. THE PHYSICIAN THE CONNECTED THE ROTALINK BURR 1.50MM AND ADVANCER. RESISTANCE WAS FELT WHILE CONNECTING THE TWO PARTS TOGETHER. THE DEVICES ROTATIONAL SPEED WAS SET AT 150.000 RPM. DURING THE FIRST ROTABLATION INSIDE THE PATIENT THE SPEED SUDDENLY JUMPED TO 198.000 RPM. THE PHYSICIAN STOPPED THE ROTABLATION AND EXCHANGED THE BURR FOR A NEW BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PROBLEMS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441337 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 16690729

    Patients

    Seq Age Sex Outcome Treatment
    1