BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4090864 · Received September 15, 2014

    Report

    Report Number
    2134265-2014-05440
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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, AND RETRACT. THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION. AN OPEN HOLE AT THE LAP JOINT SHEATH ASSEMBLY WAS OBSERVED. FLUID WAS LEAKING AT THE SHEATH LAP JOINT JUNCTION BETWEEN THE BLUE SHEATHS AND CLEAR IMAGING WINDOW TUBING. A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. IMAGING CORE WINDUP WAS NOT FOUND IN THE TELESCOPE ASSEMBLY. 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 THE DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT A MISSING IMAGE OCCURRED. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN ORDER TO VISUALIZE THE UNKNOWN TARGET LESION. HOWEVER, WHEN THE IMAGING CATHETER WAS CONNECTED INTO THE ILAB ULTRASOUND IMAGING SYSTEM DURING PREPARATION, IMAGE FAILED TO APPEAR. FURTHERMORE, IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE ILAB ULTRASOUND IMAGING SYSTEM USED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE LAP JOINT SHEATH ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568427 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518110 16739912

    Patients

    Seq Age Sex Outcome Treatment
    1