BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4221619 · Received November 3, 2014

    Report

    Report Number
    2134265-2014-06584
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 5, 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

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. AFTER DEVICE ANALYSIS, THE FOLLOWING WERE OBSERVED: THE TELESCOPE ASSEMBLY WAS ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER MEASURED WAS WITHIN SPECIFICATION. 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. A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT A LOST IMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN ORDER TO VISUALIZE THE LESION, HOWEVER, UPON ADVANCING THE DEVICE LOST IMAGE OCCURRED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD. HOWEVER, AFTER DEVICE ANALYSIS, IT WAS REVEALED THAT AN OPEN HOLE WAS OBSERVED AT THE SHEATH LAP JOINT SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703086 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17107598

    Patients

    Seq Age Sex Outcome Treatment
    1