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

Model Number	M0061902220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter state/province: (b)(6).Imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a stent replacement procedure in the ureter performed on (b)(6) 2023.During the procedure, outside the patient, the stent was separated when removing the suture.The procedure was successfully completed with another tria firm ureteral stent device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported a tria firm ureteral stent was used during a stent replacement procedure in the ureter performed on (b)(6) 2023.During the procedure, the stent was separated when removing the suture.The procedure was successfully completed with another tria firm ureteral stent device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Initial reporter state/province: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h10: the returned tria ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was detached.Their respective positioner and stabilizer returned in good conditions and their suture was returned unloaded and cut.Additionally, the suture hole was torn.During functional analysis, a mandrel of 0,039 was used and pass through stent without resistance.No other problems with the device were noted.The reported event of "stent.Shaft break" was not confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, and no abnormalities were reported during the assembly process.The stent was found with its bladder coil detached and suture hole torn.The shaft was not broken.The suture was returned unloaded and cut, which indicates they tried to remove the suture and the stent was used.The detached bladder coil and torn suture hole could have been due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during it use in procedure, these factors could have caused the detachment and torn observed.If the suture string/retrieval line is intended to be removed before procedure the instructions for use (ifu) states, the following: "the line may be removed before stent placement.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line." according to the time of event, it occurred in the procedure.Consequently, affect the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16878085
• Report Number: 3005099803-2023-02264
• Device Sequence Number: 12576871
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 05/09/2025
• Device Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Device Lot Number: 0029375486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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: Unknown