BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JINRO PIGTAIL

    MDR report key: 21402844 · Received February 18, 2025

    Report

    Report Number
    2124215-2025-05255
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GBO
    Adverse Event
    Yes
    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 71-80 YEARS OLD. BLOCK B3: THE EVENT DATE WAS APPROXIMATED BASED ON THE REPORTED TIMELINE OF FOUR WEEKS POST-PROCEDURE. 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 PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF "THE PATIENT EXPERIENCED HYDRONEPHROSIS PAIN." IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A JINRO PIGTAIL NEPHROSTOMY CATHETER SET WAS USED FOR URINE DRAINAGE DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. FOUR WEEKS POST-DISCHARGE, THE PATIENT EXPERIENCED HYDRONEPHROSIS PAIN CAUSED BY CATHETER OCCLUSION DUE TO CATHETER CALCIFICATION. DRAINAGE WAS UNSUCCESSFUL DURING THE CATHETER'S INDWELLING PERIOD. NO INTERVENTION WAS REPORTED, AND THE CATHETER WAS REMOVED ON (B)(6) 2025. PER PHYSICIAN'S ASSESSMENT, THE EVENT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572817 JINRO PIGTAIL CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO BOSTON SCIENTIFIC CORPORATION M0064202020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other