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

Model Number M0061902330

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.

Event Description

It was reported to boston scientific that a tria firm ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2024.During insertion, when the stent was advanced through the guidewire, it was noted that they had difficulty advancing the stent.The stent was removed and found some folds in the coil part.The procedure was completed with another of different size of tria firm ureteral stent.There were no patient complications reported.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Block h10: the returned tria ureteral stent was analyzed, and upon magnification and media inspection it was observed that the renal and bladder coil kinked.Additionally, the suture and positioner were not returned.The mandrel 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible to conclude that the kinks may have been generated due to excessive manipulation of the stent before being inserted over the guidewire.Once the device is bent, if the insertion continues, the kinks could generate difficulty in advancing over the guidewire.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific that a tria firm ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2024.During insertion, when the stent was advanced through the guidewire, it was noted that they had difficulty advancing the stent.The stent was removed and found some folds in the coil part.The procedure was completed with another of different size of tria firm ureteral stent.There were no patient complications reported.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: TRIA FIRM
• 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: 19109916
• MDR Text Key: 340361114
• Report Number: 2124215-2024-21133
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729937913
• UDI-Public: 08714729937913
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K190603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: M0061902330
• Device Catalogue Number: 1983-01
• Device Lot Number: 0032415931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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