BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4173779 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06428
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. DEVICE ANALYSIS REVEALED THAT THE OUTER TELESCOPE TUBING WAS DETACHED FROM THE ANCHOR SEAL HOUSING. DUE TO THIS DETACHMENT, THE DEVICE CANNOT BE PROPERLY FLUSHED. FLUID LEAKS FROM THIS JUNCTION. IMPEDANCE TESTING FINDS THE DEVICE IS CAPABLE OF IMAGING PROPERLY. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE DETACHED TELESCOPE TUBING. THIS EXPOSES THE IMAGING CORE AND COULD CAUSE IT TO WINDUP DURING TESTING. 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

    IT WAS REPORTED THAT A SHEATH DETACHMENT OCCURRED. DURING PREPARATION FOR AN UNKNOWN PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN ORDER TO VISUALIZE THE UNKNOWN TARGET LESION. UPON FLUSHING OF THE DEVICE, IT WAS NOTED THAT THE OUTER SHEATH WAS DETACHED AND EXPOSING THE IMAGING CORE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHEATH DETACHMENT OCCURRED. DURING PREPARATION FOR AN UNKNOWN PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN ORDER TO VISUALIZE THE UNKNOWN TARGET LESION. UPON FLUSHING OF THE DEVICE, IT WAS NOTED THAT THE OUTER SHEATH WAS DETACHED AND EXPOSING THE IMAGING CORE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654354 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17152600

    Patients

    Seq Age Sex Outcome Treatment
    1