BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3190281 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04359
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE (SLED) WAS RETURNED FOR EVALUATION. ALL INVESTIGATION PROCEDURES AND TESTING, INCLUDING DECONTAMINATION, WERE PERFORMED. THE RETURNED PULLBACK SLED APPEARS NORMAL AND NO DAMAGE WAS OBSERVED. DURING FUNCTIONAL TESTING USING A TEST CATHETER, THE SLED WORKS PROPERLY AND WAS ABLE TO PROPERLY PULL BACK. NO ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-04360 AND MDR ID# 2134265-2013-04361. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, THE SLED WOULD NOT MECHANICALLY PULLBACK. DURING AN IVUS PROCEDURE, IT WAS NOTED THAT THE SLED OF THE ILAB IMAGING SYSTEM WOULD NOT MECHANICALLY PULLBACK. THE PROCEDURE WAS COMPLETED WITH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-04360 AND MDR ID# 2134265-2013-04361. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, THE SLED WOULD NOT MECHANICALLY PULLBACK. DURING AN IVUS PROCEDURE, IT WAS NOTED THAT THE SLED OF THE ILAB IMAGING SYSTEM WOULD NOT MECHANICALLY PULLBACK. THE PROCEDURE WAS COMPLETED WITH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291094 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200 S1002727

    Patients

    Seq Age Sex Outcome Treatment
    1