Tria™ Soft M0061903330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729959946), received between Jan 5, 2022 and Jul 22, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT STUDY PROCEDURE IN THE RIGHT AND LEFT URETER PERFORMED ON (B)(6) 2020 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2020, THE TRIA URETERAL STENT WAS SUCCESSFULLY PLACED IN THE RIGHT URETER UNDER FLUOROSCOPY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. DISCHARGE MEDICATIONS INCLUDED ALPHA BLOCKER, ANTICHOLINERGIC, AND PHENAZOPYRIDINE. ON (B)(6) 2020, THE LEFT SIDE STENT WAS EXPLANTED AND ON (B)(6) 2020, THE RIGHT SIDE STENT WAS EXPLANTED WITH NO ASSOCIATED ADVERSE EVENT. NO ISSUES WERE NOTED WITH THE DEVICES DURING STENT REMOVAL. ON (B)(6) 2020, THE PATIENT EXPERIENCED MILD URINARY TRACT INFECTION POSSIBLY RELATED TO THE STENT REMOVAL PROCEDURE. AUGMENTIN, UNASYN, ACETAMINOPHEN MEDICATION WERE GIVEN TO THE PATIENT. THE ADVERSE EVENT WAS REPORTED TO BE RESOLVE ON (B)(6) 2020. THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT WAS REPORTEDLY NOT RELATED. THERE WERE NO NEW DEVICE IMPLANTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 15089593 ↗
• InjuryJun 21, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENT WAS USED IN A STENT PLACEMENT STUDY PROCEDURE IN THE RIGHT URETER PERFORMED ON (B)(6) 2021 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2021, THE TRIA URETERAL STENT WAS SUCCESSFULLY PLACED IN THE RIGHT URETER UNDER FLUOROSCOPY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ON (B)(6) 2021, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTICED THAT THE STENT MIGRATED. THE STENT WAS SUCCESSFULLY REMOVED WITHOUT ANY DIFFICULTY. GENERAL ANESTHESIA FOR PAIN CONTROL WAS REQUIRED. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES DURING REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760655 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRIA URETERAL STENTS WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE LEFT URETER UNDER CYSTOSCOPY, PERFORMED ON (B)(6) 2021 AS PART OF THE (B)(6) CLINICAL STUDY. THE STENT PLACEMENT PROCEDURE WAS INDICATED FOR STONE MANAGEMENT ; CYSTOSCOPY AND LEFT URETEROSCOPY WITH URETERAL STENT PLACEMENT. ON (B)(6) 2021, THE LEFT SIDE STENT WAS SUCCESSFULLY IMPLANTED TO THE PATIENT. THE PATIENT WAS PRESCRIBED WITH ACETAMINOPHEN, ALPHA BLOCKER, ANTIBIOTIC, NARCOTIC ANALGESICS AND NSAIDS AT DISCHARGE. NO ISSUES WERE NOTED WITH THE DEVICES. POST PROCEDURE, THE PATIENT EXPERIENCED SEVERE PAIN THAT LASTED FOR THREE WEEKS. ON (B)(6) 2021, THE LEFT SIDE STENT WAS REMOVED SUCCESSFULLY AS PER INITIAL PLAN. STENT WAS NOT DIFFICULT TO REMOVE AND ORAL PAIN MEDICATION WAS REQUIRED. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2021. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE EVENT IS POSSIBLY RELATED, THERE IS NO RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE BSC GUIDEWIRE, THE STENT IMPLANT PROCEDURE, AND THE STENT REMOVAL PROCEDURE, A 'CASUAL' RELATIONSHIP BETWEEN THE ADVERSE EVENT. BOSTON SCIENTIFIC HAS BE

  Patient problems: Pain

  MAUDE report 13169925 ↗