BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3770629 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02342
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING DEVICE ANALYSIS, THE FOLLOWING WERE OBSERVED THAT THERE WAS NO DAMAGE ON THE DISTAL TIP OR GUIDEWIRE EXIT PORT ASSEMBLY. A TEST GUIDEWIRE (0.014") 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. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMAGING CATHETER GOT STUCK IN LESION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS POSTEROLATERAL OF LEFT CIRCUMFLEX. AFTER THE OPTICROSS¿ IMAGING CATHETER CROSSED THE TARGET LESION, PULLBACK WAS PERFORMED. UPON WITHDRAWAL OF THE IMAGING CATHETER, IT WAS UNABLE TO BE REMOVED DUE TO RESISTANCE. THE PHYSICIAN THEN SLIGHTLY PUSHED AND ROTATED THE DEVICE AND WAS ABLE TO SUCCESSFULLY REMOVE IT. A NON-BSC GUIDEWIRE WHICH WAS CROSSED GOT ENTANGLED WITH THE IMAGING CATHETER AND WAS REMOVED AS A ONE UNIT. IT WAS CONFIRMED THAT THE GUIDEWIRE WINDED UP WITH THE IMAGING CATHETER. THE GUIDEWIRE WAS UNABLE TO CONTINUE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMAGING CATHETER GOT STUCK IN LESION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND SEVERELY TORTUOUS POSTEROLATERAL OF LEFT CIRCUMFLEX. AFTER THE OPTICROSS IMAGING CATHETER CROSSED THE TARGET LESION, PULLBACK WAS PERFORMED. UPON WITHDRAWAL OF THE IMAGING CATHETER, IT WAS UNABLE TO BE REMOVED DUE TO RESISTANCE. THE PHYSICIAN THEN SLIGHTLY PUSHED AND ROTATED THE DEVICE AND WAS ABLE TO SUCCESSFULLY REMOVE IT. A NON-BSC GUIDEWIRE WHICH WAS CROSSED GOT ENTANGLED WITH THE IMAGING CATHETER AND WAS REMOVED AS A ONE UNIT. IT WAS CONFIRMED THAT THE GUIDEWIRE WINDED UP WITH THE IMAGING CATHETER. THE GUIDEWIRE WAS UNABLE TO CONTINUE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250233 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16714873

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:SION/ASAHI INTEC