BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 21718960 · Received March 28, 2025

    Report

    Report Number
    2124215-2025-16282
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K160514, K222568.

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K160514, K222568. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL INSPECTION WAS PERFORMED, AND NO ISSUES OR FOREIGN MATTER WERE OBSERVED IN THE RETURNED PACKAGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HAIR (FOREIGN MATTER) WITHIN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HAIR (FOREIGN MATTER) WITHIN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693270 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0034945442 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown