CONTOUR VL
Report
- Report Number
- 2124215-2025-89766
- Event Type
- Malfunction
- Date Received
- December 9, 2025
- Date of Event
- November 12, 2025
- Report Date
- January 30, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729067993
- PMA / PMN Number
- K974541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT. BLOCK D6A HAS BEEN CORRECTED. BLOCK H11: INVESTIGATION ANALYSIS. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS CONTOUR URETERAL STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS DID NOT IDENTIFY ANY DAMAGES TO THE RETURNED DEVICE. FUNCTIONAL EVALUATION REVEALED THAT A MANDREL OF 0.039 WAS INSERTED INTO THE STENT TO EVALUATE IF SOME RESISTANCE IS FELT INSIDE THE DEVICE, HOWEVER, NO RESISTANCE WAS FELT DURING THE ANALYSIS PERFORMED AND THE MANDREL WAS ABLE TO FULLY PASS THROUGH THE STENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED ALLEGATION OF STENT BUCKLED MATERIAL AND STENT/DELIVERY SYSTEM DIFFICULT TO ADVANCE WAS NOT CONFIRMED. A CONCLUSION CODE OF NO PROBLEM DETECTED WAS ASSIGNED TO THIS INVESTIGATION.
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT. BLOCK E1 INITIAL REPORTER EMAIL, HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION PROVIDED ON DECEMBER 08, 2025.
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT.
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING INSERTION, WHEN THE STENT WAS INSERTED THROUGH THE WIRE AND POSITIONER, IT WAS NOTICED THAT THE STENT WAS WRINKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING INSERTION, WHEN THE STENT WAS INSERTED THROUGH THE WIRE AND POSITIONER, IT WAS NOTICED THAT THE STENT WAS WRINKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING INSERTION, WHEN THE STENT WAS INSERTED THROUGH THE WIRE AND POSITIONER, IT WAS NOTICED THAT THE STENT WAS WRINKLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440137 | CONTOUR VL | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M006180156010 | 0033516912 | 08714729067993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |