BARD® INLAY OPTIMA® URETERAL STENT
Report
- Report Number
- 1018233-2024-07154
- Event Type
- Injury
- Date Received
- November 13, 2024
- Date of Event
- October 19, 2024
- Report Date
- February 22, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FAD
- UDI-DI
- 00801741015762
- PMA / PMN Number
- K043193
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: INDICATIONS FOR USE: THE INLAY OPTIMA URETERAL STENT AND MULTI LENGTH URETERAL STENT WITH SUTURE ARE INDICATED TO RELIEVE OBSTRUCTION IN A VARIETY OF BENIGN, MALIGNANT AND POST TRAUMATIC CONDITIONS IN THE URETER. THESE CONDITIONS INCLUDE STONES AND OR STONE FRAGMENTS, OR OTHER URETERAL OBSTRUCTIONS SUCH AS THOSE ASSOCIATED WITH URETERAL STRICTURE, MALIGNANCY OF ABDOMINAL ORGANS, RETROPERITONEAL FIBROSIS OR URETERAL TRAUMA, OR IN ASSOCIATION WITH EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL). THE STENT MAY BE PLACED USING ENDOSCOPIC SURGICAL TECHNIQUES OR PERCUTANEOUSLY USING STANDARD RADIOGRAPHIC TECHNIQUE. IT IS RECOMMENDED THAT THE INDWELLING TIME NOT EXCEED 365 DAYS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE. DESCRIPTION: THE INLAY OPTIMA URETERAL STENT AND MULTI-LENGTH URETERAL STENT IS A COATED, DOUBLE PIGTAIL URETERAL STENT WITH A MONOFILAMENT SUTURE LOOP ATTACHED TO AID IN STENT REMOVAL. THE STENT IS AVAILABLE IN TWO FORMS: A SINGLE SIZE OR A CUSTOMIZABLE MULTI LENGTH SIZE. THE FOLLOWING ITEMS ARE INCLUDED WITH EACH STENT: URETERAL STENT WITH SUTURE PUSH CATHETER WITH RADIOPAQUE BAND PIGTAIL STRAIGHTENER GUIDEWIRE (OPTIONAL) NOTE: A 4.7 FR STENT IS COMPATIBLE WITH A .035 GUIDEWIRE AND 6, 7, AND 8 FR STENTS ARE COMPATIBLE WITH A .038 GUIDEWIRE. IN VITRO TESTING CONDUCTED ON THE INLAY OPTIMA URETERAL STENT AND MULTI-LENGTH URETERAL STENT INDICATE REDUCED ACCUMULATION OF URINE CALCIUM SALTS AS ASSAYED BY CALCIUM WHEN COMPARED TO A CONTROL. CORRELATION OF IN VITRO DATA TO CLINICAL OUTCOME HAS NOT BEEN ESTABLISHED. CHOONG, SKS, WOOD, S, WHITFIELD, HN. A MODEL TO QUANTIFY ENCRUSTATION ON URETERIC STENTS, URETHRAL CATHETERS, AND POLYMERS INTENDED FOR UROLOGICAL USE. CONTRAINDICATIONS: NO KNOWN CONTRAINDICATIONS FOR USE. PRECAUTIONS: SUTURE MAY BE CUT OFF PRIOR TO STENT PLACEMENT. REMOVE SUTURE IF INDWELLING TIME IS EXPECTED TO BE LONGER THAN 14 DAYS. AVOID IMPROPER HANDLING OF STENT SUCH AS BENDING, KINKING, TEARING, ETC. MISUSE COULD DAMAGE THE OVERALL INTEGRITY OF THE STENT. URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PATIENT¿S CONDITION AND OTHER PATIENT SPECIFIC FACTORS. WHEN LONG-TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 365 DAYS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE. WITH ANY URETERAL STENT, MIGRATION IS A POSSIBLE COMPLICATION, WHICH COULD REQUIRE MEDICAL INTERVENTION FOR REMOVAL. SELECTION OF TOO SHORT A STENT MAY RESULT IN MIGRATION. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT FROM THE INNER POLYBAG TO ELIMINATE TEARING OR FRAGMENTATION. 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. MULTI-LENGTH URETERAL STENTS: FORMATION OF KNOTS IN MULTI-LENGTH URETERAL STENTS MAY OCCUR. THIS MAY RESULT IN INJURY TO THE URETER DURING REMOVAL AND OR THE NEED FOR ADDITIONAL SURGICAL INTERVENTION. THE PRESENCE OF A KNOT SHOULD BE CONSIDERED IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING ATTEMPTS AT REMOVAL. POTENTIAL COMPLICATIONS: POTENTIAL COMPLICATIONS ASSOCIATED WITH RETROGRADE/ANTEGRADE POSITIONING OF INDWELLING URETERAL STENTS INCLUDE THE FOLLOWING: EDEMA, STONE FORMATION, PERITONITIS EXTRAVASATION, URETERAL REFLUX, STENT DISLOGDGEMENT FISTULA FORMATION, LOSS OF RENAL FUNCTION FRAGMENTATION, MIGRATION, OCCLUSION HEMORRHAGE, PAIN OR DISCOMFORT, STENT ENCRUSTATION HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL, URETERAL EROSION INFECTION PELVIS, URETER AND OR BLADDER, URINARY SYMPTOMS DIRECTIONS FOR USE: 1. 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. 2. INSERT THE CYSTOSCOPE THEN PASS THE GUIDEWIRE THROUGH THE SCOPE UNTIL THE TIP IS IN THE RENAL PELVIS. 3. MOVE THE PIGTAIL STRAIGHTENER OVER THE PROXIMAL END (KIDNEY COIL END) OF THE URETERAL STENT ALLOWING EASIER INSERTION ONTO THE GUIDEWIRE. REMOVE PIGTAIL STRAIGHTENER ONCE THE STENT IS SECURE ON THE GUIDEWIRE. 4. PASS THE STENT OVER THE GUIDEWIRE THROUGH THE CYSTOSCOPE BY USING THE PUSH CATHETER FOR PROPER PLACEMENT. 5. WATCH THE DISTAL END (BLADDER COIL END) OF THE STENT OR THE RADIOPAQUE, PROXIMAL END OF THE PUSHER. STOP ADVANCING WHEN THE STENT¿S DISTAL END MARKER REACHES THE URETEROVESICAL JUNCTION (UVJ). 6. WITHDRAW THE GUIDEWIRE SLOWLY. THE STENT WILL FORM A PIGTAIL AUTOMATICALLY. 7. CAREFULLY REMOVE THE PUSH CATHETER. ACTIVATE THE GUIDEWIRE COATING ACCORDING TO THE ¿INSTRUCTIONS FOR USE¿ FOUND WITHIN THE GUIDEWIRE PACKAGING. MULTI-LENGTH URETERAL STENT PLACEMENT: TO ACCURATELY SIZE THIS STENT COUNT THE MARKER BANDS AS IT IS BEING ADVANCED INTO THE URETER. THE FIRST LARGE BAND INDICATES THE 22CM LENGTH. THE SECOND AND THIRD BANDS INDICATE 24CM AND 26CM LENGTHS RESPECTIVELY. THE LAST LARGE BAND IS THE 28CM LENGTH. IF YOU NEED TO PLACE FOR THE 30CM AND 32CM LENGTHS, USE THE ATTACHED SUTURE OR ENDOSCOPIC FORCEPS TO GENTLY PULL BACK ON THE STENT UNWINDING THE COIL FROM THE KIDNEY. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. THIS IS A SINGLE USE DEVICE. DO NOT RE-STERILIZE ANY PORTION OF THIS DEVICE. REUSE AND OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT." UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.
IT WAS REPORTED THAT THE ACCORDING TO THE DOCTOR INSTRUCTION , BARD DOUBLE J TUBE INSTRUCTIONS INDICATE THAT IT CAN BE LEFT IN PLACE FOR 12 MONTHS TO PREVENT AGGRAVATION OF URETERAL OBSTRUCTION AND INFECTION, URETERAL STENT IMPLANTED ON (B)(6) 2024.ON (B)(6) 2024 THE PATIENT WAS ASKED TO INCREASE ABDOMINAL PRESSURE DURING THE IMPLANTATION PROCESS WITHOUT DISPLACEMENT, AND THEN ON THE LOCAL HOSPITAL B ULTRASOUND EXAMINATION SHOWED THAT THE BARD DOUBLE J TUBE MOVED DOWNWARD, AND IN THE REPLACEMENT OF THE CATHETER, A LARGE AMOUNT OF PUS WAS VISIBLE UNDER CYSTOSCOPY, AND THE BARD DOUBLE J TUBE WAS WRAPPED. THE CYSTOSCOPY TO REMOVE THE BARD DOUBLE J TUBE, REPLACE THE DOMESTIC DOUBLE J TUBE DRAINAGE OF THE LEFT URETER, ANTI-INFECTION THERAPY.
IT WAS REPORTED THAT THE ACCORDING TO THE DOCTOR INSTRUCTION, BARD DOUBLE J TUBE INSTRUCTIONS INDICATE THAT IT CAN BE LEFT IN PLACE FOR 12 MONTHS TO PREVENT AGGRAVATION OF URETERAL OBSTRUCTION AND INFECTION, URETERAL STENT IMPLANTED ON (B)(6)T2024. ON (B)(6)2024 THE PATIENT WAS ASKED TO INCREASE ABDOMINAL PRESSURE DURING THE IMPLANTATION PROCESS WITHOUT DISPLACEMENT, AND THEN ON THE LOCAL HOSPITAL B ULTRASOUND EXAMINATION SHOWED THAT THE BARD DOUBLE J TUBE MOVED DOWNWARD, AND IN THE REPLACEMENT OF THE CATHETER, A LARGE AMOUNT OF PUS WAS VISIBLE UNDER CYSTOSCOPY, AND THE BARD DOUBLE J TUBE WAS WRAPPED. THE CYSTOSCOPY TO REMOVE THE BARD DOUBLE J TUBE, REPLACE THE DOMESTIC DOUBLE J TUBE DRAINAGE OF THE LEFT URETER, ANTI-INFECTION THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1513099 | BARD® INLAY OPTIMA® URETERAL STENT | URETERAL STENT | FAD | C.R. BARD, INC. (COVINGTON) -1018233 | NGHU2247 | 00801741015762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |