BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4182106 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06261
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT 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 WAS MEASURED, THE OBSERVED DISTANCE IS 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. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 THE DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT SALINE LEAK FROM THE SHEATH CONJUNCTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING AN UNSPECIFIED PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED DURING INTRAVASCULAR ULTRASOUND (IVUS). THE PHYSICIAN THEN TOOK THE DEVICE OUT. UPON FLUSHING THE IMAGING CATHETER, THE NURSE NOTED A SALINE CAME OUT FROM THE SHEATH CONJUNCTION POINT INSTEAD OF THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. 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
    660756 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518120 16909493

    Patients

    Seq Age Sex Outcome Treatment
    1