BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4243606 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06971
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 21, 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 MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE 99% TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED UNSPECIFIED CORONARY ARTERY. A 2.15MM ROTALINK¿ PLUS WAS SELECTED TO TREAT THE TARGET LESION. DURING INTRODUCTION, SEVERE RESISTANCE WAS ENCOUNTERED WHEN THE DEVICE WAS ADVANCED INSIDE THE GUIDING CATHETER WITH DYNAGLIDE MODE AND THE DESIRED SPEED OF THE DEVICE WAS 200,000RPM. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND ATTEMPTED TO READJUST THE ROTATIONAL SPEED, HOWEVER THE ROTATIONAL SPEED WAS UNSTEADY. THE PHYSICIAN DECIDED TO STOP USING THE DEVICE AND COMPLETED THE PROCEDURE WITH A NON BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726977 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310150 16022009

    Patients

    Seq Age Sex Outcome Treatment
    1