BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GUIDEWIRE

    MDR report key: 23369509 · Received October 23, 2025

    Report

    Report Number
    1018233-2025-09466
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 12, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. INITIAL REPORTER NAME: (B)(6) HOSPITAL. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME: (B)(6) HOSPITAL, (B)(6) CORPORATION. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE FRACTURE AND RETENTION IN THE BODY. IN A PNL CASE PERFORMED IN 2017, DESPITE THE PACKAGE INSERT FOR THE END ACCESS GUIDEWIRE STATING THAT THE CONCURRENT USE WITH METAL NEEDLES WAS CONTRAINDICATED AND THE PROCEDURE WAS CARRIED OUT USING BOTH THE END ACCESS SHEATHS AND A METAL NEEDLE. SUBSEQUENTLY, THE PATIENT DEVELOPED KIDNEY STONES AND UNDERWENT SURGERY FOR KIDNEY STONES IN (B)(6) 2025. DURING THAT SURGERY, FRAGMENTS OF THE END ACCESS USED IN THE 2017 PNL WERE DISCOVERED, REVEALING THAT PARTS OF THE DEVICE HAD REMAINED IN THE BODY. THE CATALOG NUMBER OF THE END ACCESS (GUIDE WIRE) IN QUESTION WAS UNKNOWN, AND IT HAD NOT BEEN DETERMINED WHETHER IT WAS INCLUDED WITH THE INLAY OPTIMUS TENT OR WHETHER IT WAS A STANDALONE ITEM MANUFACTURED BY PIOLAX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE FRACTURE AND RETENTION IN THE BODY. IN A PNL CASE PERFORMED IN 2017, DESPITE THE PACKAGE INSERT FOR THE END ACCESS GUIDEWIRE STATING THAT THE CONCURRENT USE WITH METAL NEEDLES WAS CONTRAINDICATED AND THE PROCEDURE WAS CARRIED OUT USING BOTH THE END ACCESS SHEATHS AND A METAL NEEDLE. SUBSEQUENTLY, THE PATIENT DEVELOPED KIDNEY STONES AND UNDERWENT SURGERY FOR KIDNEY STONES IN (B)(6) 2025. DURING THAT SURGERY, FRAGMENTS OF THE END ACCESS USED IN THE 2017 PNL WERE DISCOVERED, REVEALING THAT PARTS OF THE DEVICE HAD REMAINED IN THE BODY. THE CATALOG NUMBER OF THE END ACCESS (GUIDE WIRE) IN QUESTION WAS UNKNOWN, AND IT HAD NOT BEEN DETERMINED WHETHER IT WAS INCLUDED WITH THE INLAY OPTIMUS TENT OR WHETHER IT WAS A STAND ALONE ITEM MANUFACTURED BY PIOLAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777584 UNKNOWN GUIDEWIRE GUIDEWIRE FAD C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention