BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3191086 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04458
    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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-04459 AND 2134265-2013-4896. 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
    289581 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 15607507

    Patients

    Seq Age Sex Outcome Treatment
    1