BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 20750412 · Received November 21, 2024

    Report

    Report Number
    2124215-2024-70725
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 10/01/2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - ADDITIONAL PREMARKET / 510(K): K222568.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - ADDITIONAL PREMARKET / 510(K): K222568. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN ANALYSIS WAS CONCLUDED BASED ON THE RECEIVED PHOTO OF THE COMPLAINT DEVICE. THE MEDIA SHOWS THE IMAGING WINDOW TWISTED AND KINKED, AND THE IMAGING CORE WAS OBSERVED TWISTED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GETS ALL TWIRLED UP AND CANNOT BE USED AGAIN. KINK WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GETS ALL TWIRLED UP AND CANNOT BE USED AGAIN. KINK WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014553 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown