BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3102988 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03232
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED KINKS ALONG THE BODY. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03231. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END TO MID LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT A POPPING SOUND WAS HEARD FROM THE ROTA CONSOLE THEN ROTATION SPEED WAS UNABLE TO INCREASE. THE PHYSICIAN THEN REMOVED THE 1.5 MM ROTABLATOR ROTALINK BURR. IT WAS NOTED THAT THE 1.5 MM ROTALINK BURR TESTED FINE OUTSIDE THE PATIENT. HOWEVER, REGURGITATION OCCURRED IN INTRAVENOUS LINE OF THE BURR, AND IT WAS OBSERVED THAT THE BURR WAS LODGED AT APPROXIMATELY 5 CM SHORT OF THE GUIDING CATHETER. THE BURR WAS SUCCESSFULLY REMOVED TOGETHER WITH THE ROTA WIRE AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03231. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE 90% STENOSED TARGET LESION WAS LOCOATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL END TO MID LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT A POPPING SOUND WAS HEARD FROM THE ROTA CONSOLE THEN ROTATION SPEED WAS UNABLE TO INCREASE. THE PHYSICIAN THEN REMOVED THE 1.5M ROTABLATOR ROTALINK BURR. IT WAS NOTED THAT THE 1.5MM ROTALINK BURR TESTED FINE OUTSIDE THE PATIENT. HOWEVER, REGURGITATION OCCURRED IN INTRAVENOUS LINE OF THE BURR, AND IT WAS OBSERVED THAT THE BURR WAS LODGED AT APPROXIMATELY 5CM SHORT OF THE GUIDING CATHETER. THE BURR WAS SUCCESSFULLY REMOVED TOGETHER WITH THE ROTA WIRE AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204245 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention