BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3952464 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04296
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 30, 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). THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE CATHETER WAS RECEIVED WITH THE CLEAR IMAGING WINDOW DETACHED FROM THE BLUE SHEATH TUBING AT LAP JOINT SEAM. THIS EXPOSES THE IMAGING CORE. WATER WAS LEAKING FROM THE BLUE SHEATH TUBING AT THE DETACHED LAP JOINT SECTION DURING THE FLUSHING PROCESS. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULLBACK OR ADVANCE DUE TO THE DETACHED IMAGING WINDOW. IMPEDANCE TESTING FINDS THAT THERE WAS NO ELECTRICAL DISCONNECT IN THE IMAGING CIRCUIT. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE IMAGING WINDOW DETACHED FROM THE BLUE SHEATH TUBING AT THE LAP JOINT SEAM. THE DETACHMENT EXPOSES THE IMAGING CORE WHICH MIGHT ONSET A WINDUP OF THE IMAGING CORE WHEN A FUNCTIONAL TEST IS PERFORMED. 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. DURING A PERCUTANEOUS CORONARY INTERVENTION AN OPTICROSS¿ WAS USED TO DIAGNOSE A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION LOCATED AT THE PROXIMAL END OF THE LEFT CIRCUMFLEX ARTERY WITH 90 PERCENT STENOSIS. THE SHAFT OF THIS DEVICE WAS KINKED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE CLEAR IMAGING WINDOW DETACHED FROM THE BLUE SHEATH TUBING AT LAP JOINT SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430892 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16766810

    Patients

    Seq Age Sex Outcome Treatment
    1