BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3983895 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04898
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 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).

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TELESCOPE 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 WITHIN SPECIFICATIONS. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0 MM AND RIPPED 1.0 MM LONG. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. 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 MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ENTRAPMENT BETWEEN IMAGING CATHETER AND GUIDEWIRE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. AFTER THE INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL OF THE OPTICROSS¿ FROM THE PATIENT. THEREFORE THE DEVICE AND THE NON-BSC GUIDEWIRE WAS REMOVED TOGETHER. AT THAT TIME THE NON-BSC GUIDEWIRE WAS FOUND TO BE DETACHED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ENTRAPMENT BETWEEN IMAGING CATHETER AND GUIDEWIRE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. AFTER THE INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, RESISTANCE WAS ENCOUNTERED UPON WITHDRAWAL OF THE OPTICROSS¿ FROM THE PATIENT. THEREFORE THE DEVICE AND THE NON-BSC GUIDEWIRE WAS REMOVED TOGETHER. AT THAT TIME THE NON-BSC GUIDEWIRE WAS FOUND TO BE DETACHED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459760 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16880430

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT:XIENCE XPEDITION| GUIDEWIRE:HI-TORQUE BALANCE MIDDLEWEIGHT ELITEII| BALLOON CATHETER:SAPPHIRE| GUIDING CATHETER:LAUNCHER