BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDU5 PLUS STERILE BAG

    MDR report key: 20621942 · Received November 6, 2024

    Report

    Report Number
    2124215-2024-69591
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    IYO
    UDI-DI
    08714729842255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 DEVICE CODES: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. AN MDU PLUS STERILE BAG WAS USED AS PART OF THE ILAB ULTRASOUND IMAGING SYSTEM FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CONNECT THE IVUS CATHETER TO THE MOTORDRIVE UNIT (MDU), BUT IT KEPT DISCONNECTING. THE SCREEN DISPLAYED AN ERROR, AND THE PHYSICIAN COULD NOT COMPLETE THE RUN. AS A RESULT, THE MDU PLUS STERILE BAG BECAME UNSTERILE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. AN MDU PLUS STERILE BAG WAS USED AS PART OF THE ILAB ULTRASOUND IMAGING SYSTEM FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CONNECT THE IVUS CATHETER TO THE MOTORDRIVE UNIT (MDU), BUT IT KEPT DISCONNECTING. THE SCREEN DISPLAYED AN ERROR, AND THE PHYSICIAN COULD NOT COMPLETE THE RUN. AS A RESULT, THE MDU PLUS STERILE BAG BECAME UNSTERILE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE BECAME UNSTERILE DUE TO THE BAG TEARING AFTER REPEATED BACK-AND-FORTH MANIPULATION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990671 MDU5 PLUS STERILE BAG SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC CORPORATION H749MDU5PLUSBAG0 0034414389 08714729842255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown