BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 3875356 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03279
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    February 6, 2014
    Report Date
    May 19, 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 MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED 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. THE SHEATH ASSEMBLY WAS FOUND TO HAVE THE CLEAR IMAGING WINDOW TUBING DETACHED FROM THE BLUE SHEATH TUBING AT THE LAP JOINT. THIS FULLY EXPOSES THE IMAGING CORE. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE IMAGING WINDOW DETACHED FROM THE BLUE SHEATH TUBING AT THE LAP JOINT SEAM. THE DETACHMENT EXPOSES THE IMAGING CORE WHICH MIGHT ONSET A WINDUP OF THE IMAGING CORE WHEN A FUNCTIONAL TEST IS PERFORMED. IN ORDER TO INSPECT FOR IMAGING CORE (IC) WINDUP AT THE PROXIMAL END OF THE CATHETER, THE RETAINER CLIP WAS REMOVED. THIS WOULD ALLOW THE IC ASSEMBLY TO BE PULLED OUT FROM THE DEVICE. THE IC OR DRIVE SHAFT WAS FOUND TO HAVE BROKEN OFF FROM THE ROTATING HUB SHAFT CONNECTOR. DUE TO THIS, THE WHOLE IC ASSEMBLY COULD NOT BE PULLED OUT FOR INSPECTION. IN ORDER TO EXPOSE THE IC FOR INSPECTION, THE TELESCOPE FEMALE TUBING WAS CUT AT THE DISTAL END OF THE ANCHOR HOUSING ASSEMBLY. THE FEMALE TELESCOPE TUBING AND BLUE SHEATH WAS THE PULLED FROM THE MALE TELESCOPE SECTION, EXPOSING THE IC CORE. NEXT, THE IC WAS THEN PULLED FREE FROM THE TELESCOPE MALE TUBING. WINDUP OF THE IC CORE 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 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 THE OUTER SHAFT WAS SEPARATED. THE 90% STENOSED TARGET LESION IS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MIDDLE OF THE RIGHT CORONARY ARTERY (RCA). DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS IMAGING CATHETER WAS USED TO VIEW A LESION. UPON PULLBACK IT WAS REPORTED THAT THE OUTER SHEATH OF THE CATHETER WAS SEPARATED AT THE DISTAL STRAIN RELIEF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CLEAR IMAGING WINDOW TUBING IS DETACHED FROM THE BLUE SHEATH TUBING AT THE LAP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352995 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16462124

    Patients

    Seq Age Sex Outcome Treatment
    1