BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX NITINOL GUIDEWIRE

    MDR report key: 17642818 · Received August 28, 2023

    Report

    Report Number
    MW5145024
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 23, 2023
    Manufacturer
    TELEFLEX LLC (NADC)
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT, THERE WAS DIFFICULTY ADVANCING THE ACCUSTICK SYSTEM OVER THE MICROWIRE. THE MICROWIRE WAS PHYSICALLY INSPECTED AND NO CLEAR HIGH GRAD KINKING OR DAMAGE TO THE PORTION OF WIRE THAT THE ACCUSTICK SYSTEM WOULD NOT ADVANCE OVER. DURING RETRYING TO REPLACE THE ACCUSTICK SYSTEM OVER THE WIRE, THE WIRE SNAPPED AND BROKE. THE WIRE WAS SUCKED INTO THE RIGHT RENAL COLLECTION SYSTEM. ATTEMPTS WERE MADE TO RETRIEVE THE RETAINED FRAGMENT WITHOUT SUCCESS. UROLOGY WAS CONSULTED WITH THE PLAN TO REMOVE THE WIRE AFTER THE PATIENT STABILIZED FROM THE SEPTIC EVENT. THE PATIENT WAS TAKEN TO OPERATING ROOM ON (B)(6) 2023 FOR UROLOGY TO REMOVE THE RETAINED WIRE FRAGMENT. PATIENT PRESENTED TO THE EMERGENCY ROOM FROM THEIR NURSING HOME FOR SEIZURE LIKE ACTIVITY. PATIENT WAS TRANSFERRED TO THE CCU AFTER INTUBATION FOR MANAGEMENT OF SEPTIC SHOCK, HYPOXIC RESPIRATORY FAILURE, SEIZURE LIKE ACTIVITY, BILATERAL URETERAL CALCULI WITH BILATERAL HYDRONEPHROSIS, ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815174 TELEFLEX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX TELEFLEX LLC (NADC) TUNGSTEN COIL TIP 722109

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention