BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4152676 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06264
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 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. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE TELESCOPE FEMALE TUBING WAS FOUND DETACHED FROM THE ANCHOR SEAL ASSEMBLY. THE TELESCOPE FEMALE TUBING AND BLUE SHEATH ASSEMBLY WAS SEPARATED FROM THE IMAGING CORE WHEN RECEIVED. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION DUE TO THE DETACHMENT, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE TELESCOPE DETACHED. THE DETACHMENT EXPOSES THE IMAGING CORE WHICH MIGHT ONSET A WINDUP 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER SHEATH WAS DETACHED. DURING THE PREPARATION TO PERFORM A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS WAS USED TO DIAGNOSE AN UNKNOWN LESION. WHEN THE DEVICE WAS TESTED OUTSIDE THE PATIENT'S BODY, IT WAS NOTICED THAT THE OUTER SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND NO PATIENT'S COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER SHEATH WAS DETACHED. DURING THE PREPARATION TO PERFORM A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS WAS USED TO DIAGNOSE AN UNKNOWN LESION. WHEN THE DEVICE WAS TESTED OUTSIDE THE PATIENT'S BODY, IT WAS NOTICED THAT THE OUTER SHEATH WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND NO PATIENT'S COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630374 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17151010

    Patients

    Seq Age Sex Outcome Treatment
    1