BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4223928 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-06620
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 12, 2014
    Report Date
    October 9, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AT 34.0 CM FROM FEMORAL MARKER TO THE PROXIMAL END. FLUID WAS LEAKING FROM AN OPEN HOLE IN THE IMAGING WINDOW 86.5CM FROM THE FEMORAL MARKER AT THE DISTAL END WHEN THE CATHETER WAS FLUSHED. 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. IT WAS ALSO FOUND THAT THE IMAGING CORE OR DRIVE SHAFT WAS BROKEN AT THE HUB. 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 LOST IMAGE OCCURED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MIDDLE RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ IMAGING CATHETER WAS USED. HOWEVER, IMAGE WAS LOST DUE TO WINDUP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE IN THE IMAGING WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708365 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17052222

    Patients

    Seq Age Sex Outcome Treatment
    1