BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3252997 · Received July 29, 2013

    Report

    Report Number
    2134265-2013-05196
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE MDU5 WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT DOES NOT MEET SPECIFICATIONS FOR FUNCTIONAL TESTING. THE CAUSE OF THE PULLBACK FAILURE WAS A DEFECTIVE ASSEMBLY CLUTCH. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-05198 AND 2134265-2013-05197. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 75% STENOSED AND MILDLY CALCIFIED LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH ATLANTIS SR PRO2 INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK BECAUSE THE CLUTCH LEVER WAS DISABLED. AUTOMATIC PULLBACK WAS ATTEMPTED 2 TO 3 TIMES AND THEY PERFORMED MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-05198 AND 2134265-2013-05197. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 75% STENOSED AND MILDLY CALCIFIED LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH ATLANTIS SR PRO2 INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK BECAUSE THE CLUTCH LEVER WAS DISABLED. AUTOMATIC PULLBACK WAS ATTEMPTED 2 TO 3 TIMES AND THEY PERFORMED MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352657 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000008191

    Patients

    Seq Age Sex Outcome Treatment
    1