BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4243529 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-07130
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 21, 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. BASED ON THE RETURNED CONDITION OF THE DEVICE. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, AND 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. DURING FLUSHING, FLUID WAS LEAKING DUE TO AN OPEN HOLE AT THE SHEATH LAP JOINT JUNCTION BETWEEN THE BLUE SHEATH AND CLEAR IMAGING WINDOW TUBING. IMAGING CORE WINDUP WAS FOUND IN THE TELESCOPE ASSEMBLY. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. 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 OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (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. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ IMAGING CATHETER WAS USED. DURING THE FIRST INTRAVASCULAR ULTRASOUND, IMAGE APPEARED WITH AIR. FLUSHING WAS PERFORMED OUTSIDE THE BODY. THEN IMAGING WAS ATTEMPTED INSIDE THE BODY AGAIN BUT LOST IMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE SHEATH LAP JOINT JUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727380 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17139510

    Patients

    Seq Age Sex Outcome Treatment
    1