BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JINRO PIGTAIL

    MDR report key: 21381859 · Received February 13, 2025

    Report

    Report Number
    2124215-2025-03656
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    July 7, 2024
    Report Date
    February 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE PATIENT WAS REPORTED TO BE BETWEEN 51-60 YEARS OLD. BLOCK B3: THE EVENT DATE WAS APPROXIMATED BASED ON THE PROCEDURE DATE. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A051201 CAPTURES THE REPORTABLE EVENT OF CATHETER DISLODGEMENT.

    Description of Event or Problem · 0

    AS REPORTED THAT A JINRO PIGTAIL NEPHROSTOMY CATHETER SET WAS USED TO ESTABLISH PERCUTANEOUS NEPHROSTOMY ACCESS AND URINE DRAINAGE ANTEGRADE PYELOGRAPHY DURING A PERCUTANEOUS NEPHROSTOMY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PATIENT'S HOSPITALIZATION, THE CATHETER BECAME DISLODGED WITHOUT CAUSING ANY SERIOUS ADVERSE EVENTS. NO FURTHER INTERVENTION WAS NECESSARY, AND THE CATHETER WAS REMOVED ON (B)(6) 2024. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126078 JINRO PIGTAIL CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0064202020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female