BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 3021701 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-02011
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY THE 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 2134265-2013-01922, MDR ID 2134265-2013-02012. IT WAS REPORTED THAT DURING PREPARATION FOR AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, FAILURE TO PULLBACK OCCURRED. WHILE USING AN ILAB CART SYSTEM, THE PHYSICIAN SELECTED AN ATLANTIS PRO IMAGING CATHETER FOR PRETEST. DURING PRETESTING, AUTOMATIC PULLBACK WAS ATTEMPTED BUT FAILED. IT WAS NOTED THAT AUTOMATIC PULLBACK WAS ATTEMPTED THREE TO FOUR TIMES. NO MANUAL PULLBACK PERFORMED. ANOTHER CATHETER WAS USED BUT THE SAME PROBLEM OCCURRED. AS A RESULT, THE MOTOR DRIVE UNIT STOPPED WORKING INTERMITTENTLY AFTER THE TEST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124260 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1