BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4760217 · Received May 8, 2015

    Report

    Report Number
    2134265-2015-02967
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 15, 2015
    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 MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE MDU WAS RECEIVED BY FREMONT CIS WITH A MISSING PULLBACK GEAR ON THE CLUTCH ASSEMBLY. THE UNIT DOES NOT MEET SPECIFICATIONS FOR FUNCTIONAL TEST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE HAS BEEN DETERMINED TO BE WEAR AND TEAR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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# 2134265-2015-02897 AND 2134265-2015-02896. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PROCEDURE, AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN ATLANTIS¿ SR PRO IMAGING CATHETER AND A SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT THE AUTOMATIC RETRACTION OF THE SLED DID NOT WORK. THE MDU5 HAD BROKEN. MANUAL RETRACTION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2015-02897 AND 2134265-2015-02896. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PROCEDURE, AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN ATLANTIS¿ SR PRO IMAGING CATHETER AND A SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT THE AUTOMATIC RETRACTION OF THE SLED DID NOT WORK. THE MDU5 HAD BROKEN. MANUAL RETRACTION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303965 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240CART0 0000006055

    Patients

    Seq Age Sex Outcome Treatment
    1