BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3952447 · Received July 23, 2014

    Report

    Report Number
    2134265-2014-04374
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 29, 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 THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. 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. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE DETACHED TELESCOPE TUBING. 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. IT WAS REPORTED THAT POOR IMAGE OCCURRED AND IT WAS UNABLE TO REMOVE AIR FROM THE DEVICE. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS WAS USED TO DIAGNOSE AN UNKNOWN LESION WITH 90 PERCENT STENOSIS. DESPITE FLUSHING THE DEVICE 5 OR 6 TIMES AIR WAS STILL UNABLE TO BE REMOVED. SINCE IMAGE WAS POOR, THE DEVICE WAS REMOVED FROM THE PATIENT BEFORE PERFORMING PULLBACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE WITH NO ISSUE. NO PATIENT COMPLICATIONS 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
    430083 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16825354

    Patients

    Seq Age Sex Outcome Treatment
    1