BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3021699 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01922
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE AVAIL FOR EVAL, RETURNED TO MFR ON, DEVICE RETURNED FOR EVAL, DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE PROBLEM COULD NOT BE REPRODUCED AS INDICATED IN THE ORIGINAL COMPLAINT. 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). DEVICE EVALUATED BY THE MANUFACTURER: 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 2134265-2013-02011, MDR ID 2134265-2013-02012. IT WAS REPORTED THAT DURING PREPARATION FOR AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, FAILURE TO PULLBACK OCCURRED. WHILE USING AN ILAB CART SYSTEM, THE PHYSICIAN SELECTED AN ATLANTIS PRO IMAGING CATHETER FOR PRETEST. DURING PRETESTING, AUTOMATIC PULLBACK WAS ATTEMPTED BUT FAILED. IT WAS NOTED THAT AUTOMATIC PULLBACK WAS ATTEMPTED THREE TO FOUR TIMES. NO MANUAL PULLBACK PERFORMED. ANOTHER CATHETER WAS USED BUT THE SAME PROBLEM OCCURRED. AS A RESULT, THE MOTOR DRIVE UNIT STOPPED WORKING INTERMITTENTLY AFTER THE TEST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02011, MDR ID 2134265-2013-02012. IT WAS REPORTED THAT DURING PREPARATION FOR AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, FAILURE TO PULLBACK OCCURRED. WHILE USING AN ILAB CART SYSTEM, THE PHYSICIAN SELECTED AN ATLANTIS PRO IMAGING CATHETER FOR PRETEST. DURING PRETESTING, AUTOMATIC PULLBACK WAS ATTEMPTED BUT FAILED. IT WAS NOTED THAT AUTOMATIC PULLBACK WAS ATTEMPTED THREE TO FOUR TIMES. NO MANUAL PULLBACK PERFORMED. ANOTHER CATHETER WAS USED BUT THE SAME PROBLEM OCCURRED. AS A RESULT, THE MOTOR DRIVE UNIT STOPPED WORKING INTERMITTENTLY AFTER THE TEST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123365 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB220CART0 0000006516

    Patients

    Seq Age Sex Outcome Treatment
    1