BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 23919097 · Received December 29, 2025

    Report

    Report Number
    2124215-2025-93621
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 9, 2025
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. MEDIA PROVIDED BY THE CUSTOMER SHOWS LOST IMAGE BUT DOES NOT SHOW ENOUGH EVIDENCE TO IDENTIFY A DEVICE DEFECT THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. G4: PREMARKET / 510(K) #: K160514, K222568.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K160514, K222568. INVESTIGATION RESULTS: MEDIA REVIEW: MEDIA PROVIDED BY THE CUSTOMER SHOWED A LOST IMAGE. DEVICE ANALYSIS FINDINGS: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE TIP WAS KINKED AND AN IMAGING CORE WINDUP BEGAN 23.5 CM FROM THE DISTAL END OF THE CONNECTOR SHAFT. IMPEDANCE TESTING SHOWED AN ELECTRICAL OPEN AT THE PROXIMAL. 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. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: THIS INVESTIGATION WAS CONCLUDED AS FAILURE TO FOLLOW INSTRUCTIONS BASED ON A REVIEW OF THE EVENT DETAILS, AVAILABLE INFORMATION, RETURNED DEVICE ANALYSIS, AND PRODUCT RECORDS. DURING PRODUCT ANALYSIS, THE TWISTED IMAGING WINDOW AND DRIVE CABLE INDICATE THAT THE DEVICE WAS ADVANCED WHILE ROTATING, WHICH IS NOT IN ACCORDANCE WITH THE IFU. THE DEVICE IS NOT DESIGNED TO WITHSTAND THE FORCES ENCOUNTERED UNDER THESE CONDITIONS, WHICH CAN RESULT IN EXCESSIVE TORQUE AND TWISTING OF THE DRIVE CABLE. PER THE IFU, THE MDU SHOULD REMAIN OFF DURING DEVICE INSERTION. FOR THE REPORTED SHEATH DETACHMENT OF DEVICE OR DEVICE COMPONENT, THE CAUSE WAS DETERMINED TO BE NO PROBLEM DETECTED, AS THE DEVICE PERFORMED AS INTENDED DURING ANALYSIS AND NO DAMAGE WAS IDENTIFIED THAT COULD SUPPORT THE REPORTED ALLEGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 91% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION OVER A V-18 WIRE. CLEAR IVUS IMAGES WERE INITIALLY OBTAINED. HOWEVER, WHEN THE LESION BECAME VERY TIGHT, THE IMAGE TURNED BLACK. THE CATHETER WAS PULLED BACK THROUGH THE LESION AND FLUSHED BUT THE IMAGE DID NOT RETURN. UPON REMOVING THE IVUS, IT WAS NOTED THAT THE CATHETER HAD COME OFF THE WIRE, AND THE MONORAIL SECTION OF THE CATHETER WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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. THE 91% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION OVER A V-18 WIRE. CLEAR IVUS IMAGES WERE INITIALLY OBTAINED. HOWEVER, WHEN THE LESION BECAME VERY TIGHT, THE IMAGE TURNED BLACK. THE CATHETER WAS PULLED BACK THROUGH THE LESION AND FLUSHED BUT THE IMAGE DID NOT RETURN. UPON REMOVING THE IVUS, IT WAS NOTED THAT THE CATHETER HAD COME OFF THE WIRE, AND THE MONORAIL SECTION OF THE CATHETER WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129623 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0037343632 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown