BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3883761 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03998
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    March 12, 2014
    Report Date
    May 22, 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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE SHEATH ASSEMBLY WAS FOUND TO HAVE THE CLEAR TUBING DETACHED FROM THE BLUE TUBING AT THE LAP JOINT. THIS FULLY EXPOSES THE IMAGING CORE. DURING IMPEDANCE TESTING, OPEN AT PROXIMAL WAS OBSERVED. IMAGING CORE WIND UP IN THE HUB ASSEMBLY WAS OBSERVED DURING X-RAY ANALYSIS. THE IMAGING CORE WAS BROKEN OFF FROM THE HUB, WHICH WAS ALSO OBSERVED DURING X-RAY ANALYSIS. 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT LOST IMAGE ENCOUNTERED. THE OPTICROSS¿ IMAGING CATHETER WAS USED TO VISUALIZE TARGET LESION IN THE RIGHT CORONARY ARTERY. IT WAS NOTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, THE SHEATH WAS FOUND DETACHED FROM THE BLUE TUBING AT THE LAP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362088 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16683367

    Patients

    Seq Age Sex Outcome Treatment
    1