BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4182186 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06196
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 23, 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 MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED: A KINK WAS OBSERVED IN THE IMAGING WINDOW ASSEMBLY AT 91.5CM FROM FEMORAL MARKER TO THE DISTAL END; THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, AND 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; 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; DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL; IN ORDER TO INSPECT IMAGING CORE WINDUP AT THE PROXIMAL END OF THE CATHETER, THE RETAINER CLIP WAS REMOVED AND IMAGING CORE ASSEMBLY WAS PULLED OUT FROM HUB. IC WINDUP WAS FOUND IN THE TELESCOPE ASSEMBLY. 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 OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT LOSS OF IMAGE OCCURRED. THE 90% STENOSED, MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE RIGHT DISTAL CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS WAS USED. WHEN THIS DEVICE WAS INSERTED INTO AN UNKNOWN GUIDING CATHETER AND WAS BEING ADVANCED INTO THE LESION IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE LAP JOINT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661505 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17090823

    Patients

    Seq Age Sex Outcome Treatment
    1