BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 18880517 · Received March 11, 2024

    Report

    Report Number
    2124215-2024-14677
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 17, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 MODEL NUMBER, CATALOG NUMBER AND UNIQUE IDENTIFIER (UDI): CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE BAGS TEARS OCCURRED. DURING INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION, MULTIPLE PERMANENT SLED STERILE BAGS USED TO COVER THE MOTOR DRIVE UNIT (MDU) WERE RIPPED DURING PREPARATION OR DURING REINSERTION OF THE OPTICROSS CATHETER. THE BAG HAS GOTTEN CAUGHT UNDER THE MDU AND RIPPED AND HAS ALSO RIPPED ON THE CATHETER HUB IN THE MDU SLED. A NEW BAG WAS OPENED AND IVUS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS. THE EXACT NUMBER OF INCIDENTS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE BAGS TEARS OCCURRED. DURING INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION, MULTIPLE PERMANENT SLED STERILE BAGS USED TO COVER THE MOTOR DRIVE UNIT (MDU) WERE RIPPED DURING PREPARATION OR DURING REINSERTION OF THE OPTICROSS CATHETER. THE BAG HAS GOTTEN CAUGHT UNDER THE MDU AND RIPPED AND HAS ALSO RIPPED ON THE CATHETER HUB IN THE MDU SLED. A NEW BAG WAS OPENED AND IVUS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS. THE EXACT NUMBER OF INCIDENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010782 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown