BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4111386 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05650
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    May 13, 2014
    Report Date
    August 29, 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 ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS OBSERVED TO BE WITHIN THE PRODUCT SPECIFICATION. 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. THE IMAGING WINDOW WAS STILL CONNECTED TO THE BLUE SHEATH TUBING AT THE LAP JOINT. THE LAP JOINT HOLE WAS ON THE OUTSIDE SECTION OF THE BOND JUNCTION. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IN ORDER TO INSPECT FOR IMAGING CORE (IC) WINDUP AT THE PROXIMAL END OF THE CATHETER, THE HUB ROTATOR RETAINER CLIP WAS REMOVED. THE ROTATOR AND IMAGING CORE ASSEMBLY WAS PULLED OUT FROM HUB. IC WINDUP WAS FOUND WITHIN THE TELESCOPE SECTION OF THE DEVICE. NO OTHER ISSUES OR DEFECTS WERE OBSERVED. 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 THE IMAGE DISAPPEARED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED. IMAGE DISAPPEARED DURING 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 AN OPEN HOLE AT THE SHEATH LAP JOINT SECTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590410 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16721697

    Patients

    Seq Age Sex Outcome Treatment
    1