BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3023550 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-02239
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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#: 2134265-2013-02201 AND 2134265-2013-02238. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, IMAGING CATHETER WAS UNABLE TO BE PULLED BACK BY THE MOTORDRIVE UNIT OF THE ILAB IMAGING SYSTEM. THE 75% STENOSED TARGET LESION WAS LOCATED IN MILD TORTUOUS AND MILD CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A F/G ATLANTIS SR PRO² WAS USED FOR VISUALIZATION OF THE LESION. THE MOTORDRIVE UNIT (MDU) OF THE ILAB IMAGING SYSTEM WAS UNABLE TO PULL BACK THE IMAGING CATHETER. IMAGING CORE WINDUP OF THE IMAGING CATHETER WAS ALSO NOTICED. THE PROCEDURE WAS COMPLETED WITH THE SAME SLED AND MDU. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127086 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR IYO BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1