BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2970373 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00723
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 MDU-5 WAS INSTALLED INTO A GOLD STANDARD SYSTEM AND TESTED FOR FUNCTIONALITY. THE UNIT MEETS SPECIFICATIONS. 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: 2134265-2013-00741 AND 2134265-2013-00742. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, CATHETER PULL BACK DIFFICULTIES OCCURRED. THE PHYSICIAN PLACED A CORONARY CATHETER IN THE LESION AND THEN ATTEMPTED PULLBACK, BUT THE MOTOR DRIVE UNIT DID NOT RETRACT THE CATHETER. THE PROCEDURE OUTCOME WAS NOT KNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR: 2134265-2013-00741 AND 2134265-2013-00742. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, CATHETER PULL BACK DIFFICULTIES OCCURRED. THE PHYSICIAN PLACED A CORONARY CATHETER IN THE LESION AND THEN ATTEMPTED PULLBACK, BUT THE MOTOR DRIVE UNIT DID NOT RETRACT THE CATHETER. THE PROCEDURE OUTCOME WAS NOT KNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73572 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0

    Patients

    Seq Age Sex Outcome Treatment
    1