BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4111378 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05764
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 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 EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS RECEIVED WITH THE FEMALE TELESCOPE TUBING ASSEMBLY DETACHED AT THE ANCHOR SEAL HOUSING EXPOSING THE IMAGING CORE ASSEMBLY. WATER WAS LEAKING FROM THE DETACHED TELESCOPE ASSEMBLY DURING THE FLUSHING PROCESS. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULLBACK OR ADVANCE DUE TO THE DETACHED TELESCOPE TUBING. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. IMPEDANCE TESTING FINDS THAT THERE WAS NO ELECTRICAL DISCONNECT IN THE IMAGING CIRCUIT. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE TELESCOPE DETACHED. THE DETACHMENT EXPOSES THE IMAGING CORE WHICH MIGHT ONSET A WINDUP IN THE IMAGING CORE WHEN A FUNCTIONAL TEST IS PERFORMED. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT DETACHMENT OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS REMOVED FROM THE DEVICE BOX AND WAS FLUSHED. WHEN THE DEVICE WAS ATTEMPTED TO CONNECT TO MDU5, THE OUTER SHAFT WAS FOUND TO BE SEPARATED WHICH HAS SOME MARKERS EVERY 10MM AND COVERS THE INNER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT DETACHMENT OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS REMOVED FROM THE DEVICE BOX AND WAS FLUSHED. WHEN THE DEVICE WAS ATTEMPTED TO CONNECT TO MDU5, THE OUTER SHAFT WAS FOUND TO BE SEPARATED WHICH HAS SOME MARKERS EVERY 10MM AND COVERS THE INNER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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
    589593 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080

    Patients

    Seq Age Sex Outcome Treatment
    1