BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3102352 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03104
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MET SPECIFICATIONS AND 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 WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03106, MDR ID 2134265-2013-03105. IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND (IVUS), FAILURE TO PULLBACK OCCURRED. THE PHYSICIAN USED AN ILAB CART SYSTEM 240 WITH A BSC CORONARY IMAGING CATHETER AND ASSY SLED PULLBACK SINGLE PACK MD5 TO IMAGE AN UNSPECIFIED VESSEL. DURING THE PROCEDURE, AN MDU OVERLOAD ERROR OCCURRED. THE PULLBACK WOULD NOT WORK AND THE MDU WOULD NOT MOVE AT ALL. THE PHYSICIAN ATTEMPTED AUTOMATIC PULLBACK 3 TIMES AND TRIED TO CHECK THE MDU CONNECTIONS WITHOUT SUCCESS. MANUAL PULLBACK WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT FURTHER IVUS USE. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03106, MDR ID 2134265-2013-03105. IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND (IVUS), FAILURE TO PULLBACK OCCURRED. THE PHYSICIAN USED AN ILAB CART SYSTEM 240 WITH A BSC CORONARY IMAGING CATHETER AND ASSY SLED PULLBACK SINGLE PACK MD5 TO IMAGE AN UNSPECIFIED VESSEL. DURING THE PROCEDURE, AN MDU OVERLOAD ERROR OCCURRED. THE PULLBACK WOULD NOT WORK AND THE MDU WOULD NOT MOVE AT ALL. THE PHYSICIAN ATTEMPTED AUTOMATIC PULLBACK 3 TIMES AND TRIED TO CHECK THE MDU CONNECTIONS WITHOUT SUCCESS. MANUAL PULLBACK WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT FURTHER IVUS USE. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203860 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240CART0 0000006771

    Patients

    Seq Age Sex Outcome Treatment
    1