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

Model Number	M0061902420
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device problem code a04 captures the reportable event of material integrity problem.
Event or Problem Description
It was reported that, during a ureterorenoscopy procedure using a tria ureteral stent, the cosmetic of the stent at the bladder side was damaged, inside the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Block h6: device problem a0401 captures the reportable event of stent torn.Block h11: updated b5: describe event or problem.Updated block h6: device code.
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a tria ureteral stent, the coil part has a cut, and has no detached piece in the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Block h6: device problem a0401 captures the reportable event of stent torn.Block h11: correction to block d7a (sud reprocessed and reused).
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a tria ureteral stent, the coil part has a cut, and has no detached piece in the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Block h6: device problem a0401 captures the reportable event of stent torn.Block h11: the returned tria ureteral stent was analyzed, and the evaluation found that the bladder coil close to the tip buckled.Additionally, the suture did not return.Based on the most available information of the complaint, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The reported "stent torn material" the as analyzed cause code will be no problem detected since the reported problem was not detected during the analysis.Regarding to the analysis performed to the returned device, evidence the bladder coil buckled.It is possible to concluded that this problem could be caused by operational factors, interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure could have contributed to the failure, consistently leading to device being buckled.Consequently, affect the performance of the device.Based on the analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a tria ureteral stent, the coil part has a cut, and has no detached piece in the patient.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.

• Brand Name: TRIA FIRM
• Common Device Name: 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: 19584768
• Report Number: 2124215-2024-37387
• Device Sequence Number: 17017548
• Product Code: FAD
• UDI-Device Identifier: 08714729937968
• UDI-Public: 08714729937968
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2026
• Device Model Number: M0061902420
• Device Catalogue Number: 1983-01
• Device Lot Number: 0032266360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 08/20/2024; 10/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/16/2024; 09/16/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male