BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1831855 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04107
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE PRODUCT ANALYSIS COULD NOT BE PERFORMED. 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

    THE INITIAL EMDR WAS DUE ON 9/9/2010 AND WAS SUBMITTED ON 9/9/2010, BUT THERE WAS A DELAY IN PROCESSING ACKNOWLEDGEMENT 3 DUE TO AN FDA SERVER ISSUE WHICH MADE THE MDR APPEAR LATE.(B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-04108 AND 2134265-2010-04185. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE VESSEL WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED. THE UNSPECIFIED SIZED BURR AND UNSPECIFIED ROTAWIRE WERE BEING USED AT 180,000 RPMS WHEN RESISTANCE WAS FELT AND "THE BLADDER OF THE CONSOLE RELEASED AIR" WITH THE STALL LIGHT ACTIVATING ON THE CONSOLE. FLUOROSCOPY REVEALED THAT A PERFORATION OF THE VESSEL HAD OCCURRED. THE BURR AND WIRE WERE REMOVED IN THE CATH LAB. THE PATIENT WAS SYMPTOMATIC WITH TAMPONADE. PATIENT WAS SENT TO SURGERY FOR BYPASS AND A PERICARDIAL WINDOW. THE PATIENT WAS RELEASED FIVE TO EIGHT DAYS LATER.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-04108 AND 2134265-2010-04185. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE VESSEL WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED. THE UNSPECIFIED SIZED BURR AND UNSPECIFIED ROTAWIRE WERE BEING USED AT 180,000 RPM'S WHEN RESISTANCE WAS FELT AND "THE BLADDER OF THE CONSOLE RELEASED AIR" WITH THE STALL LIGHT ACTIVATING ON THE CONSOLE. FLUOROSCOPY REVEALED THAT A PERFORATION OF THE VESSEL HAD OCCURRED. THE BURR AND WIRE WERE REMOVED IN THE CATH LAB. THE PATIENT WAS SYMPTOMATIC WITH TAMPONADE. PATIENT WAS SENT TO SURGERY FOR BYPASS AND A PERICARDIAL WINDOW. THE PATIENT WAS RELEASED FIVE TO EIGHT DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK553

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention