TRIA SOFT
Report
- Report Number
- 3005099803-2020-01674
- Event Type
- Injury
- Date Received
- April 16, 2020
- Date of Event
- February 19, 2020
- Report Date
- April 13, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729959908
- PMA / PMN Number
- K191609
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK G3: CLINICAL STUDY: (B)(6). BLOCK H6: CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. ADDITIONAL INFORMATION: BLOCK B5 (EVENT DESCRIPTION). REMOVED H6 PATIENT CODE E2330 PAIN.
ADDITIONAL INFORMATION: BLOCKS B5 AND H6 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON MARCH 24, 2023. BLOCK G3: CLINICAL STUDY: U0652 DOUBLE-J REGISTRY. BLOCK H6: IMDRF PATIENT E2330 CODE CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIAURETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY PERFORMED ON (B)(6), 2020 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6), 2020, THE TRIA URETERAL STENT WAS PLACED FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ADDITIONALLY, DURING THIS PROCEDURE TWO OTHER STENTS THAT WERE PRE-STENTED ON (B)(6), 2020 WERE REMOVED. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE ON (B)(6), 2020, THE PATIENT HAD EXPERIENCED A LEFT FLANK PAIN. THE PATIENT WAS GIVEN OXYCODONE-ACETAMINOPHEN 7.5-325 TO TREAT THE PAIN. ON (B)(6), 2020 THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6), 2020, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITH A PAIR OF CYTO/GRASPERS WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL. **ADDITIONAL INFORMATION RECEIVE ON JUNE 22, 2021** THE RELATIONSHIP TO THE STUDY DEVICE HAS BEEN UPDATED FROM "UNLIKELY" BY THE SITE TO "NOT RELATED" FOR SUBJECT (B)(6) WITH ADVERSE EVENT TERM LEFT FLANK PAIN.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY PERFORMED ON (B)(6), 2020 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6), 2020, THE TRIA URETERAL STENT WAS PLACED FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ADDITIONALLY, DURING THIS PROCEDURE TWO OTHER STENTS THAT WERE PRE-STENTED ON (B)(6), 2020 WERE REMOVED. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE ON (B)(6), 2020, THE PATIENT HAD EXPERIENCED A LEFT FLANK PAIN. THE PATIENT WAS GIVEN OXYCODONE-ACETAMINOPHEN 7.5-325 TO TREAT THE PAIN. ON MARCH 4, 2020 THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6), 2020, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITH A PAIR OF CYTO/GRASPERS WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL. ADDITIONAL INFORMATION RECEIVED ON JUNE 22, 2021. THE RELATIONSHIP TO THE STUDY DEVICE HAS BEEN UPDATED FROM "UNLIKELY" BY THE SITE TO "NOT RELATED" FOR SUBJECT (B)(6) WITH ADVERSE EVENT TERM LEFT FLANK PAIN. ADDITIONAL INFORMATION RECEIVED ON MARCH 24, 2023. THE ONSET DATE OF THE WORSENING LEFT FLANK PAIN WAS UPDATED TO (B)(6), 2020. THE RELATIONSHIP TO THE STUDY DEVICE WAS UPDATED FROM "NOT RELATED" TO "PROBABLY RELATED". THE CLAVIEN-DINDO CLASSIFICATION WAS GRADED AS CLASS II.
REPORT SOURCE: CLINICAL STUDY: (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY PERFORMED ON (B)(6) 2020 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2020, THE TRIA URETERAL STENT WAS PLACED FOR STONE MANAGEMENT FOR STONES IN THE LEFT KIDNEY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ADDITIONALLY, DURING THIS PROCEDURE TWO OTHER STENTS THAT WERE PRE-STENTED ON (B)(6) 2020 WERE REMOVED. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE ON (B)(6) 2020, THE PATIENT HAD EXPERIENCED A LEFT FLANK PAIN. THE PATIENT WAS GIVEN OXYCODONE-ACETAMINOPHEN 7.5-325 TO TREAT THE PAIN. ON (B)(6) 2020 THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2020, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED WITH A PAIR OF CYTO/ GRASPERS WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433940 | TRIA SOFT | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M0061903230 | 0024550783 | 08714729959908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |