BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3090434 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02850
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE MDU 5 UNIT MEETS SPECIFICATION OF THE MDU-5 FUNCTIONAL TEST. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION SELECTED IS DESIGN . (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02851, 2134265-2013-02852. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, AN AUTOMATIC PULLBACK FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE INTRAVASCULAR ULTRASOUND PROCEDURE, THE PHYSICIAN PERFORMED A FULL AUTOMATIC PULLBACK, HOWEVER, THE MOTOR DRIVE UNIT FAILED TO PULLBACK. IT COMPLETELY STOPPED AT APPROXIMATELY 10-15MM. THREE MORE ATTEMPTS FOR AUTOMATIC PULLBACK WERE MADE BEFORE SWITCHING TO MANUAL PULLBACK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME DEVICE USING MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02851, 2134265-2013-02852. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, AN AUTOMATIC PULLBACK FAILURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE INTRAVASCULAR ULTRASOUND PROCEDURE, THE PHYSICIAN PERFORMED A FULL AUTOMATIC PULLBACK, HOWEVER, THE MOTOR DRIVE UNIT FAILED TO PULLBACK. IT COMPLETELY STOPPED AT APPROXIMATELY 10-15MM. THREE MORE ATTEMPTS FOR AUTOMATIC PULLBACK WERE MADE BEFORE SWITCHING TO MANUAL PULLBACK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME DEVICE USING MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193180 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240CART0 0000004334

    Patients

    Seq Age Sex Outcome Treatment
    1