BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 19015890 · Received April 1, 2024

    Report

    Report Number
    2124215-2024-19322
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    UDI-DI
    08714729187691
    PMA / PMN Number
    K120495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 03/01/2024 AS NO EVENT DATE WAS REPORTED. F10 PATIENT CODES CHANGED FROM FOREIGN BODY IN PATIENT E2008 TO NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS E2403. F10 DEVICE CODES CHANGED FROM FRACTURE A040101 TO DETACHMENT OF DEVICE OR DEVICE COMPONENT A0501.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2024 AS NO EVENT DATE WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL HALF TO TWO THIRDS OF THE SEPARATED CATHETER WERE WHAT WAS STUCK INSIDE THE PATIENT'S ARM JUST ABOVE THE BRACHIAL AREA UP THROUGH THE SUBCLAVIAN ARTERY AREA. THE DEVICE BECAME SO TWISTED BUT IT APPEARS TO HAVE DETACHED UPON ATTEMPTS TO REMOVE IT FROM THE BODY. AFTER WHICH IT BROKE OFF AND HAD TO BE SURGICALLY REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518524 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC CORPORATION 7840 0060519445 08714729187691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention