BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4173379 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06039
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 16, 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. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE AND RETRACT. 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. NO LEAK WAS FOUND AT THE ANCHOR SEAL HOUSING ASSEMBLY OF THE TELESCOPE DURING FLUSHING. FLUID WAS LEAKING AT THE SHEATH LAP JOINT JUNCTION BETWEEN THE BLUE SHEATH AND CLEAR IMAGING WINDOW TUBING WHEN THE CATHETER WAS FLUSHED. THE HOLE WAS ON THE OUTSIDE SECTION OF THE BOND JUNCTION. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 NOT 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 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 SOLUTION LEAKAGE OCCURED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED HOWEVER SALINE SOLUTION LEAKAGE HAS OCCURED WHEN FLUSHING WAS PERFORMED. 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 AT THE SHEATH LAP JOINT SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654188 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17036597

    Patients

    Seq Age Sex Outcome Treatment
    1