BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2883431 · Received December 21, 2012

    Report

    Report Number
    2134265-2012-08360
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE UNIT WAS RECEIVED IN GOOD CONDITION. THE UNIT MEETS SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2012-08413, MDR ID 2134265-2012-08414. IT WAS REPORTED THAT DURING THE PREPARATION FOR AN INTRAVASCULAR ULTRASOUND IMAGING (IVUS) PROCEDURE, PULLBACK FAILED. THE PHYSICIAN TRIED TO MAKE AN EVALUATION OF THE LEFT MAIN CORONARY ARTERY WITH THE ILAB BUT THE PULLBACK FUNCTION FAILED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2012-08413, MDR ID 2134265-2012-08414. IT WAS REPORTED THAT DURING THE PREPARATION FOR AN INTRAVASCULAR ULTRASOUND IMAGING (IVUS) PROCEDURE, PULLBACK FAILED. THE PHYSICIAN TRIED TO MAKE AN EVALUATION OF THE LEFT MAIN CORONARY ARTERY WITH THE ILAB BUT THE PULLBACK FUNCTION FAILED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1