TRIA? FIRM
Report
- Report Number
- 2124215-2025-62444
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- August 16, 2025
- Report Date
- December 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729937906
- PMA / PMN Number
- K190603
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL, INSIDE THE PATIENT. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H11: THE RETURNED TRIA URETERAL STENT WAS ANALYZED, AND DURING THE INSPECTION, IT WAS FOUND THAT THE STENT BLADDER COIL BUCKLED, WHICH CONFIRM THE REPORTED EVENT. THE ANALYSIS PERFORMED TO THE RETURNED DEVICE; IT IS POSSIBLE TO CONCLUDE THAT THIS PROBLEM COULD BE CAUSED BY OPERATIONAL FACTORS. BASED ON THE ANALYSIS RESULTS STENT BUCKLED, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.
BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL, INSIDE THE PATIENT. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL, INSIDE THE PATIENT. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H11: CORRECTION TO PRODUCT ANALYSIS. THE RETURNED TRIA URETERAL STENT WITH POSITIONER AND SUTURE WERE ANALYZED, AND DURING THE INSPECTION, IT WAS FOUND THAT THE STENT BLADDER COIL BUCKLED, WHICH CONFIRM THE REPORTED EVENT. THE ANALYSIS PERFORMED TO THE RETURNED DEVICE; IT IS POSSIBLE TO CONCLUDE THAT THIS PROBLEM COULD BE CAUSED BY OPERATIONAL FACTORS. BASED ON THE ANALYSIS RESULTS STENT BUCKLED, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.
IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF THE PRODUCT CRUMPLED AND DOES NOT GO IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF THE PRODUCT CRUMPLED AND DOES NOT GO IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT DURING THE PROCEDURE, THE END OF THE PRODUCT CRUMPLED AND DOES NOT GO IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305836 | TRIA? FIRM | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M0061902320 | 08714729937906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |