BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3822510 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02709
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    January 10, 2014
    Report Date
    April 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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION OF THE RETURNED DEVICE REVEALED THAT NO KINKS WERE OBSERVED ALONG THE LENGTH OF THE CATHETER. 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 25 MM. THE OBSERVED DISTANCE IS NOT 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. DEVICE WAS INSERTED INTO TEST DISPENSER COIL. LEAK IS LOCATED ON THE OUTSIDE EDGE OF THE DEVICE. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, 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 ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER KINKED AND LOST IMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DISTAL OF RIGHT CORONARY ARTERY. DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED TO VIEW THE LESION. IT WAS REPORTED THAT THE OPTICROSS¿ WAS KINKED AT THE CONNECTION PART OF THE BLUE AND CLEAR SHAFT THEN THE IMAGE DISAPPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE LAP JOINT AREA OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303730 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16519860

    Patients

    Seq Age Sex Outcome Treatment
    1