BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK PLUS

    MDR report key: 1063802 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01715
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY/STENTING PROCEDURE, DEVICE WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED. FOLLOWING SUCCESSFUL ABLATION OF AN UNSPECIFIED LESION, THE PHYSICIAN WAS REMOVING THE BURR IN DYNAGLIDE WHEN HE NOTED THAT THE WIRE WAS MOVING. IT WAS NOTED THAT THE BRAKE DEFEAT BUTTON OF THE ROTALINK ADVANCER WAS STUCK IN PLACE. THE PHYSICIAN THEN REMOVED THE ENTIRE SYSTEM WITHOUT DIFFICULTY, AND CONTINUED THE PROCEDURE WITH STENTING THE LESION. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS "OKAY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1