BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIS¿ URETERAL ACCESS SHEATH

    MDR report key: 8860690 · Received August 5, 2019

    Report

    Report Number
    1018233-2019-04442
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Report Date
    October 3, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741101717
    PMA / PMN Number
    K160861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. THE EVALUATION OF THE RETURNED SAMPLE, SUBMITTED BY FUTUREMATRIX INTERVENTIONAL, STATES THAT WHEN THE INSIDE OF THE SHEATH WAS VISUALLY OBSERVED, NO DEFORMITIES WERE NOTED. THE DIMENSIONAL EVALUATION INDICATES THAT BOTH THE SHEATH MET SPECIFICATIONS. THE REPORT ALSO STATES THAT THE DHR WAS REVIEWED, AND THE PART MET SPECIFICATION REQUIREMENTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿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." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 KIDNEY STONE GOT CAUGHT IN THE PROXIS ACCESS SHEATH DURING REMOVAL. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KIDNEY STONE GOT CAUGHT IN THE PROXIS ACCESS SHEATH DURING REMOVAL. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656607 PROXIS¿ URETERAL ACCESS SHEATH PROXIS ACCESS SHEATH FED C.R. BARD, INC. (COVINGTON) -1018233 231235 BMBZFM29 00801741101717

    Patients

    Seq Age Sex Outcome Treatment
    1