BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3191316 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04896
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-04459 AND #2134265-2013-04458. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE ROTATIONAL ATHERECTOMY SPEED BECAME UNSTABLE. A 1.75MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY SYSTEM WAS SELECTED AND ADVANCED TO TREAT THE SEVERELY CALCIFIED LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS AN ABNORMAL SOUND, IT WAS ALSO FURTHER NOTED THAT THE ROTATIONAL SPEED OF THE BURR WAS UNSTABLE. THEY REPLACED THE DEVICE WITH ANOTHER 1.75MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY SYSTEM BUT THE SAME SOUND AND UNSTABLE SPEED ISSUES OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289831 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H80222020039L1

    Patients

    Seq Age Sex Outcome Treatment
    1