BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 24888516 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20437
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K160514, K222568 INVESTIGATION RESULTS: MEDIA REVIEW: MEDIA PROVIDED BY THE CUSTOMER SHOWED IMAGE POOR DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: THIS INVESTIGATION HAS BEEN ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED FOLLOWING A REVIEW OF THE REPORTED EVENTS DETAILS, AVAILABLE INFORMATION, AND PRODUCT RECORD REVIEW. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, LIMITING FURTHER ASSESSMENT. IMPROPER HANDLING, DEVICE MANIPULATION, OR NOT FOLLOWING INSTRUCTIONS MAY HAVE CONTRIBUTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE. DURING THE PROCEDURE, THE IMAGE SHOWN WAS UNUSABLE. BRIGHTNESS WAS ADJUSTED AND THE DEVICE WAS FLUSHED TO TRY AND FIX AIR BUBBLES. TWO MORE CATHETERS HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE. DURING THE PROCEDURE, THE IMAGE SHOWN WAS UNUSABLE. BRIGHTNESS WAS ADJUSTED AND THE DEVICE WAS FLUSHED TO TRY AND FIX AIR BUBBLES. TWO MORE CATHETERS HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344904 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0038531044 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1