BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 6176988 · Received December 15, 2016

    Report

    Report Number
    2134265-2016-11672
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2016-11671. IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR TIBIA. A 1.25MM PERIPHERAL ROTALINK® PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING INTRODUCTION, OUTSIDE THE PATIENT'S BODY, IT WAS NOTED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. THE BURR WAS PULLED BACK OFF THE ROTAWIRE AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829172 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK379

    Patients

    Seq Age Sex Outcome Treatment
    1