MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRIA FIRM URETERAL STENT SETS; STENT, URETERAL

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a tria firm ureteral stent sets was successfully implanted during a ureteroscopy stent placement procedure in the kidney and bladder.On (b)(6) 2024, prior to discharge, they had difficulty viewing the stents under the fluoroscopy, where the curl is in the kidney during x-ray.It was noted that the implanted stent migrated into the bladder.The implanted stent was successfully removed, and the procedure was successfully completed with another tria firm ureteral stent sets.It was noted that this happened more than one time and was a reported comments from the physician not a case complaint.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: imdrf device code a010402 captures the reportable event of stent migration.

• Brand Name: TRIA FIRM URETERAL STENT SETS
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19016516
• MDR Text Key: 339082313
• Report Number: 2124215-2024-17748
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention