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

Model Number M0061903220

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf code a0414 captures the reportable event of stent torn.

Event Description

It was reported to boston scientific corporation that tria ureteral stent was used during a ureteroscopy for kidney stone management, performed on (b)(6) 2024.During the procedure, it was found that there was a hole in the tip of the stent.The procedure was successfully completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf code a0414 captures the reportable event of stent torn.Correction: the event reported under mfr report number 2124215-2024-14663 was sent in error.Additional information was received from the complainant on march 19, 2024, the reported event of stent was torn occurred outside the patient.Therefore, this is considered non reportable.

Event Description

It was reported to boston scientific corporation that tria ureteral stent was used during a ureteroscopy in the ureter for kidney stone management, performed on (b)(6) 2024.During the procedure, it was found that there was a hole in the tip of the stent.The procedure was successfully completed with another tria ureteral stent.There were no patient complications reported as a result of this event.Additional information was received on march 19, 2024, stating that the problem occurred outside the patient.

• Brand Name: TRIA SOFT
• 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: 18887243
• MDR Text Key: 337457155
• Report Number: 2124215-2024-14663
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• 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,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0032500752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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