BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3932766 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04011
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 16, 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 RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THERE WAS AN OPEN HOLE WAS OBSERVED AT THE SHEATH LAP JOINT SECTION OF THE DEVICE. FLUID WAS LEAKING FROM THE OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY WHEN THE CATHETER WAS FLUSHED. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. THE IMAGING CORE WAS FOUND BROKEN OFF FROM THE ROTATORY ASSEMBLY¿S CONNECTOR SHAFT. THE IMAGING CORE WAS STILL WITHIN THE TELESCOPE SECTION OF THE DEVICE. IMAGING CORE WINDUP WAS FOUND WITHIN THE TELESCOPE SECTION OF THE 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT LOST IMAGE OCCURRED. THE 99% STENOSED LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. DURING THE PROCEDURE, AN OPTICROSS IMAGING CATHETER WAS USED DURING INTRAVASCULAR ULTRASOUND (IVUS); HOWEVER, LOST IMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE SHEATH LAP JOINT SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409863 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16766612

    Patients

    Seq Age Sex Outcome Treatment
    1