BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4093372 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05488
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    June 19, 2014
    Report Date
    August 21, 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 CODE # 1183 RELATES TO COMPONENT CODE # 3038. DEVICE RETURNED TO MFR: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. 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 IMAGING WINDOW WAS STILL CONNECTED TO THE BLUE SHEATH TUBING AT THE LAP JOINT. THE TELESCOPE ASSEMBLY WAS ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IMAGING CORE WINDUP WAS FOUND WITHIN THE TELESCOPE SECTION OF THE DEVICE. 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 OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    REPORTED BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT LOST IMAGE OCCURRED. THE OPTICROSS¿ IMAGING CATHETER WAS USED TO VISUALIZE TARGET LESION LOCATED IN A 90 PERCENT STENOSED, MODERATELY TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION, LOST IMAGE OCCURRED BEFORE PERFORMING THE SECOND PULLBACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571247 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16859273

    Patients

    Seq Age Sex Outcome Treatment
    1