BANDER URETERAL DIVERSION STENT SET
Report
- Report Number
- 1820334-2021-00191
- Event Type
- Malfunction
- Date Received
- January 28, 2021
- Report Date
- June 22, 2021
- Manufacturer
- COOK INC
- Product Code
- FAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
EVENT SUMMARY: AS REPORTED, DURING A PROCEDURE INVOLVING A URETERAL CUTANEOUS FISTULA USING A BANDER URETERAL DIVERSION STENT SET, THE STENT MIGRATED PROXIMALLY 3 WEEKS AFTER PLACEMENT. THE PHYSICIAN PREVIOUSLY PLACED STENTS IN BOTH SIDES OF THE URINARY DUCT WITH THE PLAN TO EXCHANGE THEM EVERY FOUR WEEKS. THE FIRST TWO EXCHANGES, THE LATTER OF WHICH INCLUDED THE PLACEMENT OF THE COMPLAINT DEVICE, WERE PERFORMED AS PLANNED. ABOUT 3 WEEKS AFTER THE DEVICE PLACEMENT, THE STENTS MIGRATED PROXIMALLY. THE RETAINERS PROVIDED WITH THE DEVICE WERE NOT USED. THE USER SUTURED THE STENT TO THE SKIN NEAR THE FISTULA. THERE WAS A NOTED DECREASE IN URINE DRAINAGE AND SLIGHT DETERIORATION OF RENAL FUNCTION BY THE RENAL FUNCTION TEST. WHEN THE DEVICE WAS EXCHANGED FOR A NEW STENT, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE PIG TAIL OF THE STENT BECAME UNCURLED AND MIGRATED PROXIMALLY INTO THE URINARY DUCT. THE PHYSICIAN THUS LOCKED/FIXED THE NEW STENT USING THREADS NEAR THE FISTULA TO PREVENT MIGRATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION REVIEWS OF THE INSTRUCTIONS FOR USE AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. NO DEVICE WAS RETURNED FOR INVESTIGATION. ACCORDINGLY, NO PHYSICAL EXAMINATION COULD BE PERFORMED. REVIEWS OF COMPLAINT HISTORY AND THE DEVICE RECORD COULD NOT BE PERFORMED DUE TO A LACK OF LOT INFORMATION. BECAUSE ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED AND NO OTHER LOT RELATED EVIDENCE IS AVAILABLE, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF DEVICE SPECIFICATIONS WAS CARRIED OUT INCLUDING QUALITY CONTROL PROCEDURES. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE, "WHEN A CATHETER RETAINER IS USED, SECURE IT BY SUTURING IT TO THE SKIN NEAR THE STOMA." IT WAS REPORTED THAT A RETAINER WAS NOT USED, AND THE STENT WAS SUTURED TO THE SKIN NEAR THE FISTULA. THE IFU LISTS MIGRATION AS A POTENTIAL ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED 12FEB2021. THE RETAINERS PROVIDED WITH THE DEVICE WERE NOT USED. THE USER SUTURED THE STENT TO THE SKIN NEAR THE FISTULA.
PMA/510K #: K181971. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING A PROCEDURE INVOLVING A URETERAL CUTANEOUS FISTULA USING A BANDER URETERAL DIVERSION STENT SET, THE STENT MIGRATED PROXIMALLY 3 WEEKS AFTER PLACEMENT. THE PHYSICIAN PREVIOUSLY PLACED STENTS IN BOTH SIDES OF THE URINARY DUCT WITH THE PLAN TO EXCHANGE THEM EVERY FOUR WEEKS. THE FIRST TWO EXCHANGES, THE LATTER OF WHICH INCLUDED THE PLACEMENT OF THE COMPLAINT DEVICE, WERE PERFORMED AS PLANNED. ABOUT 3 WEEKS AFTER THE DEVICE PLACEMENT, THE STENTS MIGRATED PROXIMALLY. THERE WAS A NOTED DECREASE IN URINE DRAINAGE AND SLIGHT DETERIORATION OF RENAL FUNCTION BY THE RENAL FUNCTION TEST. WHEN THE DEVICE WAS EXCHANGED FOR A NEW STENT, IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE PIG TAIL OF THE STENT BECAME UNCURLED AND MIGRATED PROXIMALLY INTO THE URINARY DUCT. THE PHYSICIAN THUS LOCKED/FIXED THE NEW STENT USING THREADS NEAR THE FISTULA TO PREVENT MIGRATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143136 | BANDER URETERAL DIVERSION STENT SET | FAD STENT, URETERAL | FAD | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |