BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4173766 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06339
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE OUTER TELESCOPE TUBING WAS FOUND DETACHED FROM THE ANCHOR SEAL HOUSING. THE DEVICE CANNOT BE PROPERLY FLUSHED DUE TO THIS DETACHMENT. 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 AN OUTER SHEATH DETACHMENT OCCURRED. DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS SELECTED TO VISUALIZE AN UNSPECIFIED VESSEL. HOWEVER, IT WAS NOTED THAT THE OUTER SHEATH OF THE CATHETER BECAME SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OUTER SHEATH DETACHMENT OCCURRED. DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS SELECTED TO VISUALIZE AN UNSPECIFIED VESSEL. HOWEVER, IT WAS NOTED THAT THE OUTER SHEATH OF THE CATHETER BECAME SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655509 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17151425

    Patients

    Seq Age Sex Outcome Treatment
    1