BARD® INLAY OPTIMA® URETERAL STENT
Report
- Report Number
- 1018233-2024-07083
- Event Type
- Injury
- Date Received
- November 11, 2024
- Date of Event
- October 15, 2024
- Report Date
- February 5, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FAD
- UDI-DI
- 00801741015762
- PMA / PMN Number
- K043193
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME SINCE 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 STATE THE FOLLOWING: "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 KNOT SHOULD BE CONSIDERED IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING ATTEMPTS AT REMOVAL. 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.
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.
IT WAS REPORTED THAT THERE WAS LEFT SIDE OF THE URETER OBSTRUCTION IN PATIENT, REGULAR REPLACEMENT OF DOUBLE J TUBE AND FOLLOW THE DOCTOR'S INSTRUCTIONS. BARD DOUBLE J TUBE MANUAL LABEL COULD BE LEFT 12 MONTHS, LEFT 10 MONTHS AFTER THE BLADDER END OF THE FORMATION OF HUGE STONES, COULD NOT BE REMOVED, REMOVAL PROCESS CYSTOSCOPY FOREIGN BODY FORCEPS DAMAGE, COULD NOT BE USED, THE URETHRA APPEARED OBVIOUS CRACKS, THE NEED FOR ANESTHESIA SUPERVISION LITHOTRIPSY AFTER TAKING OUT, AND THEN REPLACED DOUBLE J TUBE. PROVIDE ANESTHESIA SUPERVISION OF LITHOTRIPSY, REPLACEMENT OF DOUBLE J TUBE, LONG-TERM INDWELLING CATHETER, IF NECESSARY, URETHROGRAPHY, URETEROGRAPHY. THE PATIENT FORMED A HUGE STONE AT THE BLADDER END, WHICH WAS LATER REMOVED AFTER LITHOTRIPSY UNDER ANESTHESIA SUPERVISION.
IT WAS REPORTED THAT THERE WAS LEFT SIDE OF THE URETER OBSTRUCTION IN PATIENT, REGULAR REPLACEMENT OF DOUBLE J TUBE AND FOLLOW THE DOCTOR'S INSTRUCTIONS. BARD DOUBLE J TUBE MANUAL LABEL COULD BE LEFT 12 MONTHS, LEFT 10 MONTHS AFTER THE BLADDER END OF THE FORMATION OF HUGE STONES, COULD NOT BE REMOVED, REMOVAL PROCESS CYSTOSCOPY FOREIGN BODY FORCEPS DAMAGE, COULD NOT BE USED, THE URETHRA APPEARED OBVIOUS CRACKS, THE NEED FOR ANESTHESIA SUPERVISION LITHOTRIPSY AFTER TAKING OUT, AND THEN REPLACED DOUBLE J TUBE. PROVIDE ANESTHESIA SUPERVISION OF LITHOTRIPSY, REPLACEMENT OF DOUBLE J TUBE, LONG-TERM INDWELLING CATHETER, IF NECESSARY, URETHROGRAPHY, URETEROGRAPHY. THE PATIENT FORMED A HUGE STONE AT THE BLADDER END, WHICH WAS LATER REMOVED AFTER LITHOTRIPSY UNDER ANESTHESIA SUPERVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1818364 | 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 |