BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMAGER II UROLOGY TORQUEABLE CATHETER

    MDR report key: 16342923 · Received February 9, 2023

    Report

    Report Number
    3005099803-2023-00473
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    July 1, 2018
    Report Date
    February 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    UDI-DI
    08714729430261
    PMA / PMN Number
    K102527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE SUSPECTED LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. IMDRF PATIENT CODES E233605 CAPTURE THE REPORTABLE EVENT OF SEPTIC SHOCK. IMDRF IMPACT CODES F08 AND F2303 CAPTURE THE REPORTABLE EVENT OF READMISSION AND MEDICATION.

    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 THAT AN IMAGER II, NEPHROMAX BALLOON, INTRODUCER NEEDLES AND 8/10 DILATOR SHEATH WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN JULY 2018. THE PATIENT EXPERIENCED SEPTIC SHOCK. THE PATIENT HAD TO BE READMITTED AND WAS GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004232 IMAGER II UROLOGY TORQUEABLE CATHETER CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION M0064003001 08714729430261

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention| H