BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 22335625 · Received June 26, 2025

    Report

    Report Number
    2124215-2025-42322
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K160514, K222568.

    Additional Manufacturer Narrative · 0

    H6 DEVICE CODES; CORRECTED. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPE INSPECTIONS REVEALED THAT THE TIP WAS KINKED, AND AN IMAGING CORE WINDUP BEGAN 23.5 CM FROM THE DISTAL END OF THE CONNECTOR SHAFT. NO DAMAGE OR FAILURES WERE OBSERVED ON THE CATHETER CODE PCBA (CCP) BOARD ASSEMBLY OR ON THE HUB CONNECTOR PINS. HOWEVER, THE GUIDEWIRE EXIT PORT WAS LIFTED, AND EXCESS GREASE WAS NOTED ON THE HEAT-SHRINK TUBING NEAR THE HUB. IMPEDANCE TESTING SHOWED AN ELECTRICAL OPEN AT THE PROXIMAL END OF THE CATHETER. A FUNCTIONAL INSPECTION WAS PERFORMED USING THE MOTOR DRIVE UNIT (MDU) AND ILAB SYSTEM, WHICH CONFIRMED THAT THE CATHETER WAS PROPERLY RECOGNIZED BY THE IMAGING SYSTEM WHEN PLUGGED INTO THE MDU, WITH NO CONNECTION ISSUES OR ERRORS DETECTED. A TEST GUIDEWIRE WAS INSERTED AND TRACKED SMOOTHLY INTO THE CATHETER WITH NO INDICATION OF RESISTANCE. FLUSH TESTING SHOWED THAT THE DEVICE FLUSHED NORMALLY WHEN THE TELESCOPE WAS BOTH FULLY RETRACTED AND FULLY ADVANCED. NO SIGNS OF LEAKAGE WERE OBSERVED. G4 PREMARKET / 510(K): K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN A NON-CALCIFIED, NON-TORTUOUS VESSEL. THE OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. UPON INSERTION, THE DEVICE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE TARGET LESION WAS LOCATED IN A NON-CALCIFIED, NON-TORTUOUS VESSEL. THE OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. UPON INSERTION, THE DEVICE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529501 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036070450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown