BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 9128731 · Received September 27, 2019

    Report

    Report Number
    2134265-2019-11727
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY FROM FEMORAL MARKER TO THE DISTAL END. IT WAS OBSERVED THAT A PART OF THE FEMORAL MARKER HAS FLAKE OFF. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE LAB SYSTEM. THE COMPLAINT DEVICE WAS SENT FOR X-RAY ANALYSIS TO FURTHER CHARACTERIZE THE ELECTRICAL FAILURE. BASED ON THE X-RAY IMAGES, THE ELECTRICAL FAILURE WAS A RESULT OF A PZT CRACK.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT AN IMAGE ISSUE OCCURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTOUS AND MODERATELY CALCIFIED CORONARY ARTERY. AN OPITOCROSS IMAGING CATHETER WAS USED TO VIEW THE TARGET LESION. DURING THE INTRAVENOUS ULTRASOUND THE IMAGE SUDDENLY STOPPED. THE PROCEDURE WAS COMPLETED WITH A SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE FEMORAL MARKER WAS FLAKING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923404 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8655 0023597318

    Patients

    Seq Age Sex Outcome Treatment
    1