BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3894413 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03548
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 28, 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

    (B)(4). DEVICE RETURNED TO MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT A KINK WAS OBSERVED IN THE IMAGING WINDOW ASSEMBLY AT 67.1 CM FROM FEMORAL MARKER AT THE DISTAL END. AN OPEN HOLE WAS OBSERVED AT THE SHEATH LAP JOINT SECTION OF THE DEVICE. FLUID WAS LEAKING FROM THE OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY WHEN THE CATHETER WAS FLUSHED. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IMAGING CORE WAS FOUND WOUND UP AT THE HUB SHAFT CONNECTOR. IT WAS ALSO FOUND THAT THE IMAGING CORE OR DRIVE SHAFT WAS BROKEN WITHIN THE TELESCOPE SECTION OF THE DEVICE. 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 DEVICE ANALYSIS COMPLETED ON (B)(6) 2014. IT WAS REPORTED THAT LOST IMAGE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ WAS USED TO VIEW AN UNSPECIFIED LESION. IT WAS REPORTED THAT LOST IMAGE OCCURRED DURING THE START OF THE PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE SHEATH LAP JOINT SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371369 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16711715

    Patients

    Seq Age Sex Outcome Treatment
    1