TRIA SOFT
Report
- Report Number
- 3005099803-2022-03382
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- November 25, 2020
- Report Date
- October 6, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729959939
- PMA / PMN Number
- K191609
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
STUDY SOURCE: U0652 DOUBLE-J. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
BLOCK G3: STUDY SOURCE: U0652 DOUBLE-J BLOCK H6: PATIENT PROBLEM CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMPACT CODE F22 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED DIAGNOSTIC INTERVENTION. BLOCK H10: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED. BLOCH H11: ADDITIONAL INFORMATION BLOCK B5 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 13, 2022
BLOCK G3: STUDY SOURCE: U0652 DOUBLE-J. BLOCK H6: PATIENT PROBLEM CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMPACT CODE F22 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED DIAGNOSTIC INTERVENTION. BLOCK H10: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE FOR STONE PLACEMENT MANAGEMENT AND LASER LITHOTRIPSY IN THE LEFT KIDNEY ON (B)(6) 2020 AS PART OF THE U0652 DOUBLE-J CLINICAL STUDY. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTIC, ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE WERE GIVEN TO THE PATIENT. ON (B)(6) 2020, THE PATIENT EXPERIENCED MILD INCOMPLETE EMPTYING. THE PATIENT HAD A CATHETER INSERTION AND WAS HOSPITALIZED FROM (B)(6) 2020 TO (B)(6) 2020. THE ADVERSE EVENT WAS CONSIDERED TO BE RESOLVED AS OF NOVEMBER 27, 2020.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE FOR STONE PLACEMENT MANAGEMENT AND LASER LITHOTRIPSY IN THE LEFT KIDNEY ON (B)(6) 2020 AS PART OF THE U0652 DOUBLE-J CLINICAL STUDY. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTIC, ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE WERE GIVEN TO THE PATIENT. ON (B)(6) 2020, THE PATIENT EXPERIENCED MILD INCOMPLETE EMPTYING. THE PATIENT HAD A CATHETER INSERTION AND WAS HOSPITALIZED FROM (B)(6) 2020 TO (B)(6) 2020. THE ADVERSE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED ON 28JUN2022 STATING THAT THE ADVERSE EVENT OF MILD INCOMPLETE EMPTYING HAS BEEN INACTIVATED SINCE IT WAS REPORTED AS A DUPLICATE. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 13, 2022 STATING THAT THE RELATIONSHIP OF THE DEVICE AND THE ADVERSE EVENT OF LEFT FLANK PAIN WAS NOT RELATED. INDEPENDENT MEDICAL REVIEWER ADJUDICATED STUDY DEVICE AS POSSIBLY RELATED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE FOR STONE PLACEMENT MANAGEMENT AND LASER LITHOTRIPSY IN THE LEFT KIDNEY ON (B)(6) 2020 AS PART OF THE U0652 DOUBLE-J CLINICAL STUDY. DISCHARGE MEDICATIONS INCLUDED ANTIBIOTIC, ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE WERE GIVEN TO THE PATIENT. ON (B)(6) 2020, THE PATIENT EXPERIENCED MILD INCOMPLETE EMPTYING. THE PATIENT HAD A CATHETER INSERTION AND WAS HOSPITALIZED FROM (B)(6) 2020 TO (B)(6) 2020. THE ADVERSE EVENT WAS CONSIDERED TO BE RESOLVED AS OF NOVEMBER 27, 2020. ADDITIONAL INFORMATION RECEIVED ON 28JUN2022 STATING THAT THE ADVERSE EVENT OF MILD INCOMPLETE EMPTYING HAS BEEN INACTIVATED SINCE IT WAS REPORTED AS A DUPLICATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240995 | TRIA SOFT | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M0061903320 | 0024532589 | 08714729959939 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |