BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3113680 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03389
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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). DEVICE EVALUATED BY MANUFACTURER: 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 2134265-2013-03387, MDR ID 2134265-2013-03390. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), FAILURE TO PULLBACK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN NON-CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. WHILE USING AN ILAB IMAGING SYSTEM AND ASSY SLED PULLBACK SINGLE PACK MD5, THE PHYSICIAN SELECTED AN ATLANTIS SR PRO² TO ADVANCE THROUGH THE TARGET LESION BUT UNABLE TO PERFORM AUTOMATIC PULLBACK. THEY TRIED TO RECONNECT THE CATHETER AND USE THE CLUTCH LEVER TO SLIDE BUT IT DID NOT SOLVE THE ISSUE. MANUAL PULLBACK WAS NOT ATTEMPTED. AFTER EXCHANGING THE IMAGING CATHETER WITH ANOTHER OF THE SAME DEVICE, AUTOMATIC PULLBACK WAS PERFORMED WITHOUT PROBLEM. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214440 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR IYO BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1