BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3812698 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02658
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 6, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED WITH THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. FLUID WAS LEAKING FROM AN OPEN HOLE AT THE LAP JOINT AREA WHEN THE CATHETER WAS FLUSHED. THE IMAGING WINDOW IS STILL CONNECTED TO THE BLUE SHEATH AT THE LAP JOINT. DEVICE WAS INSERTED INTO TEST DISPENSER COIL. LEAK IS LOCATED ON THE OUTSIDE EDGE OF THE DEVICE. DURING FUNCTIONAL TESTING THE IMAGING WINDOW CAME COMPLETELY DETACHED FROM THE BLUE TUBING AT THE LAP JOINT AND THIS FULLY EXPOSES THE IMAGING CORE. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING X-RAY ANALYSIS. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT MISSING IMAGE WAS ENCOUNTERED. THE OPTICROSS IMAGING CATHETER WAS USED TO VISUALIZED 80% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. IT WAS NOTED THAT DURING SET UP FOR PERCUTANEOUS CORONARY INTERVENTION IMAGE WAS NOT APPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HOLE/PERFORATION IN THE SHEATH OF THE IMAGING WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290617 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16492871

    Patients

    Seq Age Sex Outcome Treatment
    1