BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 20625334 · Received November 6, 2024

    Report

    Report Number
    2124215-2024-68278
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET/150(K): K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WIRE TWISTED ON THE CATHETER. AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS SELECTED FOR USE. HOWEVER, THE NON-BOSTON SCIENTIFIC GUIDEWIRE TWISTED ON THE CATHETER DURING THE PROCEDURE. BOTH DEVICES WERE REMOVED AS ONE UNIT, AND THE PROCEDURE WAS COMPLETED WITH A NEW WIRE AND CATHETER. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428537 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0034352797 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown