BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4131799 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05758
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 3, 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

    (B)(4). THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. DURING FLUSHING, FLUID WAS LEAKING AT THE SHEATH LAP JOINT JUNCTION BETWEEN THE BLUE SHEATH AND CLEAR IMAGING WINDOW TUBING. THE 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 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. IT WAS ALSO FOUND THAT THE IMAGING CORE OR DRIVE SHAFT WAS BROKEN AT THE HUB. 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 LOST OCCURRED. DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN OPTICROSS¿ IMAGING CATHETER WAS USED. IT WAS NOTED THAT THE 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, DEVICE ANALYSIS REVEALED A HOLE WAS ON THE SIDE SECTION OF THE BOND JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612968 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17076109

    Patients

    Seq Age Sex Outcome Treatment
    1