BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2981207 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01148
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT DOES NOT MEET SPECIFICATIONS FOR FUNCTIONAL TEST. THE MOTOR DRIVE ROTATES ONLY MOMENTARILY PRIOR TO STOPPING. THE SHRINK TUBING INSIDE THE DRIVESHAFT ASSEMBLY IS BROKEN, PREVENTING THE DRIVESHAFT FROM ROTATING. 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). 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 2134265-2013-01151, MDR ID 2134265-2013-01152. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. WHILE USING A GALAXY 2 SYSTEM, THE PYSICIAN WAS UNABLE TO PERFORM AN AUTOMATIC PULLBACK. IT WAS NOTED THAT NO PATIENT WAS INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01151, MDR ID 2134265-2013-01152. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. WHILE USING A GALAXY 2 SYSTEM, THE PHYSICIAN WAS UNABLE TO PERFORM AN AUTOMATIC PULLBACK. IT WAS NOTED THAT NO PATIENT WAS INVOLVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83466 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (CE) H749I51370 3153

    Patients

    Seq Age Sex Outcome Treatment
    1