BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 6 HD

    MDR report key: 15439018 · Received September 16, 2022

    Report

    Report Number
    2124215-2022-36350
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 31, 2022
    Report Date
    November 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS - (B)(6).

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS - (B)(6). THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED KINKS IN THE IMAGING WINDOW ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR USE TO VIEW THE TARGET LESION. DURING PROCEDURE, THE CATHETER MALFUNCTION AND THE CATHETER CRACKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.

    Description of Event or Problem · 0

    15SEP2022 GCB IT WAS REPORTED THAT CATHETER MALFUNCTION AND THE CATHETER CRACKED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR USE TO VIEW THE TARGET LESION. DURING PROCEDURE, THE CATHETER MALFUNCTION AND THE CATHETER CRACKED. THEY WERE UNABLE TO GIVE MORE DETAILS AND SAID THEY SAVED THE CATHETER TO RETURN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE AND NONE OF THE CATHETER WAS IN THE PATIENT AFTER THE "CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126551 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8669 0029655475 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown