BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIS¿ URETERAL ACCESS SHEATH

    MDR report key: 8522220 · Received April 17, 2019

    Report

    Report Number
    1018233-2019-01966
    Event Type
    Injury
    Date Received
    April 17, 2019
    Report Date
    June 20, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741101717
    PMA / PMN Number
    K160861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿DESCRIPTION: THE PROXIS¿ URETERAL ACCESS SHEATH IS A TWO COMPONENT URETERAL DILATION SYSTEM WHICH CONTAINS A SINGLE LUMEN FOR INJECTION OF FLUIDS AS WELL AS PASSAGE OF ENDOSCOPES AND RELATED INSTRUMENTS. THE PACKAGED PRODUCT INCLUDES THE FOLLOWING ITEMS: 1 - HYDROPHILIC-COATED DILATOR WITH FEMALE LUER CONNECTOR 1 - HYDROPHILIC-COATED SHEATH WITH HUB INDICATIONS FOR USE: THE PROXIS¿ URETERAL ACCESS SHEATH IS INDICATED FOR USE IN ENDOSCOPIC UROLOGY PROCEDURES WHERE URETERAL DILATION AND URETERAL ACCESS IS DESIRED FOR INJECTION OF FLUIDS AND INSERTION AND REMOVAL OF ENDOSCOPES AND RELATED INSTRUMENTS. 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 ANTICOGAGULATIONS. ¿ 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. WARNING: FOR SINGLE USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/ OR LEAD TO DEVICE FAILURE, WHICH IN TURN, MAY RESULT IN PATIENT INJURY, ILLNESS OR DEATH. REUSE REPROCESSING OR RE-STERILIZATION MAY ALSO CREATE A RISK OF CONTAMINATION OF THE DEVICE AND/OR CAUSE PATIENT INFECTION OR CROSSINFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PATIENT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. DO NOT USE IF STERILE BARRIER IS DAMAGED. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND WITH APPLICABLE LAWS AND REGULATIONS. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. 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. TO MINIMIZE RESISTANCE DURING ADVANCEMENT, ENSURE THE HYDROPHILIC COATING ON THE DILATOR AND SHEATH IS ACTIVATED WITH SALINE OR STERILE WATER PRIOR TO PLACEMENT. DO NOT ADVANCE SHEATH WITHOUT THE DILATOR IN PLACE AS THIS COULD LEAD TO TRAUMA OR INJURY TO PATIENT. DO NOT BEND THE DEVICE PRIOR TO PLACEMENT AS THIS COULD ENGLISH RELEASED."

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTION: OUTCOMES ATTRIBUTED TO ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S URETER ALLEGEDLY TORE WHEN THE PHYSICIAN INSERTED THE PROXIS ACCESS SHEATH INTO THE URETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6)2019 FROM THE INTERNATIONAL BUSINESS CENTER REPRESENTATIVE, THE PATIENT WAS ALREADY HOSPITALIZED AT THE TIME OF THE PROCEDURE AND WAS NOT HOSPITALIZED DUE TO THE COMPLICATION. THE PROCEDURE WAS DELAYED. THERE WAS MEDICAL INTERVENTION, AS A URETHRAL STENT WAS PLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S URETER ALLEGEDLY TORE WHEN THE PHYSICIAN INSERTED THE PROXIS ACCESS SHEATH INTO THE URETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON(B)(6)2019 FROM THE INTERNATIONAL BUSINESS CENTER REPRESENTATIVE, THE PATIENT WAS ALREADY HOSPITALIZED AT THE TIME OF THE PROCEDURE AND WAS NOT HOSPITALIZED DUE TO THE COMPLICATION. THE PROCEDURE WAS DELAYED. THERE WAS MEDICAL INTERVENTION, AS A URETHRAL STENT WAS PLACED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S URETER ALLEGEDLY TORE WHEN THE PHYSICIAN INSERTED THE PROXIS ACCESS SHEATH INTO THE URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315169 PROXIS¿ URETERAL ACCESS SHEATH ACCESS SHEATH FED C.R. BARD, INC. (COVINGTON) -1018233 231235 UNK 00801741101717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R