BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4182210 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06198
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 23, 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

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS REVEALED THAT THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION. FLUID WAS LEAKING FROM AN OPEN HOLE AT THE LAP JOINT AREA WHEN THE CATHETER WAS FLUSHED. THE IMAGING WINDOW IS STILL CONNECTED TO THE BLUE SHEATH AT THE LAP JOINT. NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IMAGING CORE WINDUP WAS FOUND IN THE TELESCOPE ASSEMBLY. IMAGING CORE OR DRIVE SHAFT WAS BROKEN AT THE HUB. 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

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 23SEP2014. IT WAS REPORTED THAT A CATHETER LOST IMAGE OCCURRED. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED TO VISUALIZE AN UNSPECIFIED VESSEL. IT WAS NOTED THAT THE IMAGE DISAPPEARED UPON IMAGING. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE LAP JOINT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661574 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17051077

    Patients

    Seq Age Sex Outcome Treatment
    1