BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4251208 · Received November 14, 2014

    Report

    Report Number
    2134265-2014-06997
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SHEATH ASSEMBLY WAS FOUND TO HAVE THE CLEAR TUBING DETACHED FROM THE BLUE TUBING AT THE LAP JOINT. THIS FULLY EXPOSES THE IMAGING CORE. SINCE THE CLEAR TUBING WAS DETACHED, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. MEASUREMENT OF THE DETACHED IMAGING WINDOW IS 28.3 CM. THE CCP BOARD AND PINS APPEARED NORMAL AND A GOOD CLICK SOUND WAS HEARD DURING INSERTION INTO THE MDU SYSTEM. THE UNIT WAS CORRECTLY RECOGNIZED BY THE IMAGING SYSTEM WHEN PLUGGED INTO THE MDU DURING FUNCTIONAL TESTING. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. 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 27OCT2014. IT WAS REPORTED THAT THE 5FR OPTICROSS CATHETER WAS RECOGNIZED AS 8FR ATLANTIS PV 15 MHZ. DURING AN ASSESSMENT OF A MILDLY TOURTOUS, SEVERELY CALCIFIED LESION LOCATED AT THE OSTIUM OF THE LEFT MAIN ARTERY, AN OPTICROSS IMAGING CATHETER WAS USED. WHEN THE 5FR OPTICROSS IMAGING CATHETER WAS PLUGGED INTO THE MOTOR DRIVE UNIT, IT WAS REGISTERED AS A 8FR ATLANTIS PV 15MHZ. THE DEVICE WAS NOT ABLE TO BE USED AND DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER 5FR OPTICROSS IVUS IMAGING CATHETER WHICH REGISTERED APPROPRIATELY AND WAS ABLE TO BE USED IN A DIAGNOSTIC FASHION. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE SHEATH ASSEMBLY WAS FOUND TO HAVE THE CLEAR TUBING DETACHED FROM THE BLUE TUBING AT THE LAP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736167 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518110 17193429

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR