BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 21424978 · Received February 20, 2025

    Report

    Report Number
    2124215-2025-08157
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL HEALTHCARE FACILITY - (B)(6). G4: PREMARKET / 510(K) #: K160514, K222568. THE DEVICE WAS RETURNED FOR ANALYSIS. UPON OVERALL VISUAL INSPECTION, IT WAS IDENTIFIED THAT A GUIDEWIRE WAS LODGED WITHIN THE DEVICE. A TWIST WAS OBSERVED IN THE IMAGING WINDOW ASSEMBLY, AND BOTH THE GUIDEWIRE EXIT PORT AND THE TIP WERE FOUND TO BE DAMAGED (DEFORMED/LIFTED). BASED ON THE EVIDENCE COLLECTED, THE AS REPORTED CODE "GUIDEWIRE ENTANGLEMENT" IS CONFIRMED. THE DAMAGE TO THE EXIT PORT AND TIP, ALONG WITH THE TWIST IN THE IMAGING WINDOW ASSEMBLY DISCOVERED DURING PRODUCT ANALYSIS, LIKELY CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    E1: INITIAL HEALTHCARE FACILITY - (B)(6). G4: PREMARKET / 510(K) #: K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE ENTANGLEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC 018 GUIDEWIRE, AND IMAGES WERE TAKEN IN THE SFA AND INSIDE THE STENT IN THE SFA. WHILE IMAGING, THE CATHETER BECAME WRAPPED AROUND THE GUIDEWIRE DURING ADVANCEMENT. AS A RESULT, THE GUIDEWIRE AND IVUS CATHETER HAD TO BE WITHDRAWN DUE TO ENTANGLEMENT. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER NON-BOSTON SCIENTIFIC GUIDEWIRE AND ANOTHER OF THE SAME OPTICROSS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE ENTANGLEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC 018 GUIDEWIRE, AND IMAGES WERE TAKEN IN THE SFA AND INSIDE THE STENT IN THE SFA. WHILE IMAGING, THE CATHETER BECAME WRAPPED AROUND THE GUIDEWIRE DURING ADVANCEMENT. AS A RESULT, THE GUIDEWIRE AND IVUS CATHETER HAD TO BE WITHDRAWN DUE TO ENTANGLEMENT. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER NON-BOSTON SCIENTIFIC GUIDEWIRE AND ANOTHER OF THE SAME OPTICROSS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407851 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0031697329 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: GLADIUS 018| GUIDEWIRE: GLADIUS 018