BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3024232 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01831
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE UNIT MEETS SPECIFICATIONS. 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 ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01832, 21344265-2013-01869; 213425-2013-02505. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN ATLANTIS SR PRO2 CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION HOWEVER, THE MDU OF THE ILAB SYSTEM STOPPED DURING THE PROCEDURE. THE IMAGING CATHETER WAS THEN EXCHANGED WITH ANOTHER OF THE SAME CATHETER. UPON ADVANCING OF THE SECOND IMAGING CATHETER TOWARDS THE LESION, THE PULLBACK STOPPED AT ABOUT 70MM. THE PROCEDURE WAS THEN COMPLETED USING THE GALAXY2 SYSTEM WITH 2ND IMAGING CATHETER. NO COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01832, 21344265-2013-01869; 213425-2013-02505. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN ATLANTIS SR PRO2 CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION HOWEVER, THE MDU OF THE ILAB SYSTEM STOPPED DURING THE PROCEDURE. THE IMAGING CATHETER WAS THEN EXCHANGED WITH ANOTHER OF THE SAME CATHETER. UPON ADVANCING OF THE SECOND IMAGING CATHETER TOWARDS THE LESION, THE PULLBACK STOPPED AT ABOUT 70MM. THE PROCEDURE WAS THEN COMPLETED USING THE GALAXY2 SYSTEM WITH 2ND IMAGING CATHETER. NO COMPLICATIONS WERE REPORTED AND PATIENT¿S CONDITION IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01832, 21344265-2013-01869; 213425-2013-02505. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN ATLANTIS SR PRO2 CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION HOWEVER, THE MDU OF THE ILAB SYSTEM STOPPED DURING THE PROCEDURE. THE IMAGING CATHETER WAS THEN EXCHANGED WITH ANOTHER OF THE SAME CATHETER. UPON ADVANCING OF THE SECOND IMAGING CATHETER TOWARDS THE LESION, THE PULLBACK STOPPED AT ABOUT 70MM. THE PROCEDURE WAS THEN COMPLETED USING THE GALAXY2 SYSTEM WITH 2ND IMAGING CATHETER. NO COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126930 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000005653

    Patients

    Seq Age Sex Outcome Treatment
    1