BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 23067634 · Received September 16, 2025

    Report

    Report Number
    2124215-2025-63103
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN OBTAINED. G4: PREMARKET / 510(K) #: K222568.

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN OBTAINED. G4: PREMARKET / 510(K) #: K222568. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THE TIP WAS STRETCHED AND DETACHED FROM THE IMAGING WINDOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MESENTERIC ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE FRACTURED IN THE CELIAC ARTERY VIA THE FEMORAL APPROACH. ALL COMPONENTS REMAINED ON THE WIRE AND WERE SAFELY RETRIEVED FROM THE ARTERY AS A SINGLE UNIT. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN MESENTERIC ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE FRACTURED IN THE CELIAC ARTERY VIA THE FEMORAL APPROACH. ALL COMPONENTS REMAINED ON THE WIRE AND WERE SAFELY RETRIEVED FROM THE ARTERY AS A SINGLE UNIT. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269975 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036559770 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown