BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3477666 · Received November 19, 2013

    Report

    Report Number
    2134265-2013-08533
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. FUNCTIONAL TESTING REVEALED THAT THE DEVICE MEETS SPECIFICATIONS. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT WITHOUT ANY FAILURES OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-08536 AND 2134265-2013-08549. IT WAS REPORTED THAT MOTOR DRIVE UNIT (MDU) AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, AN ILAB WAS USED IN CONJUNCTION WITH AN ATLANTIS SR PRO IMAGING CATHETER. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE PHYSICIAN PERFORMED PULLBACK. IT WAS NOTED THAT THE AUTOMATIC PULLBACK FUNCTION OF THE MDU DID NOT WORK AND MANUAL PULLBACK WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MDU. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND SAFE THROUGHOUT THE PROCEDURE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-08536 AND 2134265-2013-08549. IT WAS REPORTED THAT MOTOR DRIVE UNIT (MDU) AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, AN ILAB WAS USED IN CONJUNCTION WITH AN ATLANTIS¿ SR PRO IMAGING CATHETER. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE PHYSICIAN PERFORMED PULLBACK. IT WAS NOTED THAT THE AUTOMATIC PULLBACK FUNCTION OF THE MDU DID NOT WORK AND MANUAL PULLBACK WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MDU. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND SAFE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598258 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1