BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3883489 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03415
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    March 5, 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 RETURNED TO MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED KINKS WERE OBSERVED IN THE TELESCOPE ASSEMBLY AT 71.6CM AND 67.3CM FROM FEMORAL MARKER TO THE PROXIMAL END. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. 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. SINCE THE CLEAR TUBING WAS DETACHED, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IN ORDER TO INSPECT IMAGING CORE WINDUP AT THE PROXIMAL END OF THE CATHETER, THE RETAINER CLIP WAS REMOVED AND IMAGING CORE ASSEMBLY WAS PULLED OUT FROM HUB. IMAGING CORE WINDUP WAS FOUND IN THE TELESCOPE ASSEMBLY. 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 DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE DRIVE SHAFT WAS STIFF AND DID NOT MOVE BACK TO THE ITS ORIGINAL POSITION. THE 90% STENOSED, MODERATELY CALCEFIED AND MODERATELY TORTUOUS LESION WAS LOCATED IN THE MIDDLE PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN OPTICROSS¿WAS USED TO VIEW THE LESION. THE DEVICE WAS USED WITHOUT ANY ISSUES DURING SET UP AND IMAGING BUT AFTER THEY ATTEMPTED AUTOMATIC PULLBACK IT WAS REPORTED THAT THE DRIVE SHAFT WAS STIFF AND IT WOULD NOT MOVE BACK TO ITS INITIAL POSITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH ASSEMBLY DETACHED FROM THE BLUE TUBING AT THE LAP JOINT AREA OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361132 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16484831

    Patients

    Seq Age Sex Outcome Treatment
    1