BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 23063619 · Received September 16, 2025

    Report

    Report Number
    2124215-2025-64777
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 25, 2025
    Report Date
    June 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K173284, K213593. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. A GOOD FAITH EFFORT WAS MADE TO OBTAIN THE BATCH/LOT NUMBER AND OTHER RELEVANT DETAILS; HOWEVER, THIS INFORMATION COULD NOT BE RETRIEVED. AS A RESULT, THE COMPLETE UDI AND OTHER PRODUCT-SPECIFIC INFORMATION ARE UNAVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PROCEDURE THE CATHETER WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE. BOTH THE CATHETER AND THE WIRE WERE PULLED OUT TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621389 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown