BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIS URETERAL ACCESS SHEATH

    MDR report key: 17358097 · Received July 20, 2023

    Report

    Report Number
    1018233-2023-05315
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 11, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741212741
    PMA / PMN Number
    K160861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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. H3 : THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. ALTHOUGH AN EXACT ROOT CAUSE COULD NOT BE DETERMINED A POTENTIAL ROOT CAUSE COULD BE MATERIAL SELECTION. THE DHR REVIEW IS NOT REQUIRED AS NO LOT NUMBER WAS REPORTED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: CONTRAINDICATIONS: PATIENTS WHO ARE CONTRAINDICATED FOR RETROGRADE UROLOGICAL PROCEDURES. PATIENTS WHO ARE CONTRAINDICATED FOR ANTEGRADE UROLOGIC PROCEDURES, INCLUDING BUT NOT LIMITED TO PATIENTS WITH BLOOD CLOTTING ANOMALIES DUE TO COAGULOPATHIES OR PHARMACOLOGICAL ANTICOAGULANTS. PATIENTS WHO HAVE THE PRESENCE OF TIGHT STRICTURES WHICH WOULD LIMIT USE OF THE DEVICE. PATIENTS WHO HAVE THE PRESENCE OF LARGE OBSTRUCTING DISTAL URETERAL CALCULI. PRECAUTIONS: THE RECOMMENDATIONS GIVEN ARE MEANT TO SERVE ONLY AS A BASIC GUIDE TO THE UTILIZATION OF THIS ACCESS SHEATH. THE URETERAL ACCESS SHEATH SHOULD NOT BE USED WITHOUT COMPREHENSIVE KNOWLEDGE OF THE INDICATIONS, TECHNIQUES AND RISKS OF THE PROCEDURE. ADVERSE EVENTS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE TRANSURETHRAL ACCESS DEVICE INCLUDE, BUT ARE NOT LIMITED TO: MUCOSAL IRRITATION, INFLAMMATION AND EDEMA; URETHRAL STRICTURES; ACUTE BLEEDING OR HEMORRHAGE; URETHRAL, BLADDER, OR URETERAL PERFORATION; OTHER INJURY TO THE URINARY TRACT. 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. H3 OTHER TEXT: THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED INFLAMMATION, URETERAL PERFORATION PRIOR TO THE DEVICE PLACEMENT AND INFLAMMATION, HEMORRHAGE COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TECHNICAL ERROR WAS NEEDED FOR HEMORRHAGE IN RELATION TO 231125 - PROXIS¿ URETERAL ACCESS SHEATH - OUTER DILATOR 11 FR/SHEATH DIAMETER 13FR, LENGTH 25CM. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED INFLAMMATION, URETERAL PERFORATION PRIOR TO THE DEVICE PLACEMENT AND INFLAMMATION, HEMORRHAGE COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TECHNICAL ERROR WAS NEEDED FOR HEMORRHAGE IN RELATION TO 231125 - PROXIS¿ URETERAL ACCESS SHEATH - OUTER DILATOR 11 FR/SHEATH DIAMETER 13FR, LENGTH 25CM. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676950 PROXIS URETERAL ACCESS SHEATH URETERAL ACCESS SHEATH FED C.R. BARD, INC. (COVINGTON) -1018233 231125 UNK 00801741212741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other