BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4111023 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05631
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 29, 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. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION OF THE RETURNED DEVICE REVEALED THAT A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AT 72.5CM FROM FEMORAL MARKER AT THE DISTAL END. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. 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. AN OPEN HOLE AT THE LAP JOINT SHEATH ASSEMBLY WAS OBSERVED. DURING FLUSHING, FLUID WAS LEAKING AT THE SHEATH LAP JOINT JUNCTION BETWEEN THE BLUE SHEATHS AND CLEAR IMAGING WINDOW TUBING. IMPEDANCE TESTING FINDS THE DEVICE IS CAPABLE OF IMAGING PROPERLY. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. 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 DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT LOST IMAGE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED TO VIEW AN UNSPECIFIED LESION. IT WAS THEN NOTED THAT THE IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE AT THE SHEATH LAP JOINT AREA OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592362 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16865886

    Patients

    Seq Age Sex Outcome Treatment
    1