BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK CATHETER

    MDR report key: 1003409 · Received February 21, 2008

    Report

    Report Number
    2134265-2008-00508
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW OF THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-00509. IT WAS REPORTED THAT SOMETIME "MID LAST YEAR" A BURR STALLED IN THE LESION. DETAILS OF THE PROCEDURE AND PT ARE UNK. THE BURR WAS EXCHANGED DURING THE PROCEDURE, AND PER THE PHYSICIAN THIS ISSUE MAY HAVE OCCURRED FOLLOWING DIFFICULTY WITH CONNECTING THE DEVICES DURING THE BURR EXCHANGE. IT WAS REPORTED THAT THE BURR WAS RECOVERED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PT COMPLICATIONS. THIS ISSUE WAS REPORTED BY THE PHYSICIAN "IN ORDER TO HIGHLIGHT THEIR NEED FOR SUPPORT AND TRAINING IN THE FUTURE WITH ROTABLATOR CASES, NOT BECAUSE THEY BELIEVED THE EVENTS WERE CAUSED BY PRODUCT FAULT OR FAILURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK CATHETER MCX CATHETER, CORONARY ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1