BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER NEEDLES

    MDR report key: 16352426 · Received February 10, 2023

    Report

    Report Number
    3005099803-2023-00641
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    August 1, 2020
    Report Date
    February 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    UDI-DI
    08714729077749
    PMA / PMN Number
    K820867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE EXACT DATE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2020. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURER DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODES E2328 AND E233605 CAPTURE THE REPORTABLE EVENT OF OBSTRUCTION/OCCLUSION AND SEPTIC SHOCK. IMDRF IMPACT CODES F2303, F0801 AND F2301 CAPTURE THE REPORTABLE EVENTS OF MEDICATION REQUIRED, INTENSIVE CARE AND ADDITIONAL DEVICE REQUIRED.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED SEPTIC SHOCK DUE TO OBSTRUCTION AND REQUIRED ADMISSION TO INTENSIVE CARE UNIT (ICU), ANTIBIOTICS, VASOPRESSOR, AND A CYSTOSCOPY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46827 INTRODUCER NEEDLES CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0067001210 08714729077749

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H