BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3931315 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04083
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 18, 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 ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK OR ADVANCE, 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 WAS OBSERVED AT THE SHEATH LAP JOINT SECTION OF THE DEVICE. FLUID WAS LEAKING FROM THE OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY WHEN THE CATHETER WAS FLUSHED. A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. NO IMAGING CORE WIND UP WAS FOUND WITHIN THE TELESCOPE SECTION OF THE DEVICE. 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 ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), LOST IMAGE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS INSERTED INTO THE PATIENT HOWEVER LOST IMAGE OCCURRED DURING THE FIRST PULLBACK. 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 A HOLE IN THE SHEATH LAP JOINT SECTION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409909 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16813654

    Patients

    Seq Age Sex Outcome Treatment
    1