BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD® INLAY OPTIMA® URETERAL STENT

    MDR report key: 12759716 · Received November 7, 2021

    Report

    Report Number
    1018233-2021-06971
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 13, 2021
    Report Date
    March 25, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAD
    UDI-DI
    00801741015779
    PMA / PMN Number
    K043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "MATERIAL SELECTION". 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: "POTENTIAL COMPLICATIONS ASSOCIATED WITH RETROGRADE/ANTEGRADE POSITIONING OF INDWELLING URETERAL STENTS INCLUDE THE FOLLOWING: ¿ EDEMA ¿ STONE FORMATION ¿ PERITONITIS ¿ EXTRAVASATION ¿ URETERAL REFLUX ¿ STENT DISLOGDGEMENT, FRAGMENTATION, MIGRATION, OCCLUSION ¿ FISTULA FORMATION ¿ LOSS OF RENAL FUNCTION ¿ HEMORRHAGE ¿ PAIN/DISCOMFORT ¿ STENT ENCRUSTATION ¿ HYDRONEPHROSIS ¿ PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND/OR BLADDER ¿ URETERAL EROSION ¿ INFECTION ¿ URINARY SYMPTOMS" "DETERMINE THE PROPER STENT LENGTH FOR THE PATIENT. THIS IS GENERALLY CALCULATED FROM THE BASELINE PYELOGRAM. ACCURATE MEASUREMENTS WILL OPTIMIZE DRAINAGE EFFICIENCY AND PATIENT COMFORT. "THE INSERTION OF A URETERAL STENT SHOULD ONLY BE DONE BY THOSE INDIVIDUALS WHO HAVE COMPREHENSIVE TRAINING IN THE TECHNIQUES AND RISKS OF THE PROCEDURE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, PAIN, DISCOMFORT, HYDRONEPHROSIS, INFECTION, AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, PAIN, DISCOMFORT, HYDRONEPHROSIS, INFECTION, AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656981 BARD® INLAY OPTIMA® URETERAL STENT URETERAL STENT FAD C.R. BARD, INC. (COVINGTON) -1018233 788628 UNK 00801741015779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other