BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F HYDROPHILIC GALTSTICK INT KIT

    MDR report key: 12124446 · Received July 6, 2021

    Report

    Report Number
    1649395-2021-00006
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 6, 2021
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    DQX
    UDI-DI
    20841268105793
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT RECEIVED BY MANUFACTURER (GALT MEDICAL) FROM FDA BY MAIL. END USER SENT MDR MED WATCH REPORT TO FDA UNDER REPORT NUMBER (B)(4) ABOUT GUIDEWIRES BROKE INSIDE THE PATIENT. THE MANUFACTURER (GALT MEDICAL) CREATED COMPLAINT RECORD NUMBER (B)(4) AND NOTIFIED END USER ABOUT THIS RECORD AND REQUESTING COMPLAINT SAMPLE TO BE RETURNED FOR EVALUATION. AT THIS MOMENT INVESTIGATION AND EVALUATION PERFORMED ON DOCUMENTATION AND COMPLAINT HISTORY REVIEW AND THERE ARE NO INCIDENTS OR ABNORMALITY INDICATED DURING MANUFACTURING PROCESS. ALL PRODUCTS AND/OR SUBCOMPONENTS MANUFACTURED TO SPECIFICATION AND PASS INSPECTIONS PER APPLICABLE CRITERIA. GALT CREATE RMA FOR END USER TO RETURN THE SAMPLE AND ONCE COMPLAINT SAMPLE RETURN THEN GALT WILL COMPLETE INVESTIGATION AND EVALUATION AND A FOLLOW-UP REPORT WILL SEND TO FDA REFERENCE TO THIS REPORT.

    Description of Event or Problem · 1

    MANUFACTURER (GALT MEDICAL) RECEIVED MED WATCH REPORT 3500A FORM BY MAIL FROM FDA ON 6/30/2021. END USER STATING THAT DURING REMOVAL OF DOUBLE J URINARY STENT A PIECE OF GALTSTICK LOT NUMBER (G21012090) 0.018 WIRE BROKE OFF INSIDE THE PATIENT'S RIGHT KIDNEY. MD ATTEMPTED AND TOOK APPROXIMATELY 2 HOURS TO SNARE AND REMOVE THIS PIECE - UNSUCCESSFULLY. WIRE REMAINED INSIDE PATIENT AT CONCLUSION OF PROCEDURE. AT THIS TIME THE MANUFACTURER (GALT MEDICAL) DOES NOT HAVE ANY OTHER INFORMATION REGARDING PATIENT STATUS AND ADDITIONAL INFORMATION REQUESTED FROM END USER TO BE PROVIDED TO GALT MEDICAL TO HELP WITH INVESTIGATION AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020982 6F HYDROPHILIC GALTSTICK INT KIT GALTSTICK INT KIT DQX GALT MEDICAL CORPORATION KIT-036-06 G21012090 20841268105793

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other