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

Model Number	M0061903230
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a procedure in the ureter, performed on (b)(6) 2022.On (b)(6) 2022, a stent removal procedure was performed.When the physician removed the stent, it was noticed that the bladder pigtail was visually defective or deformed.Another tria ureteral stent was implanted in the patient and successfully completed the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Medical device problem code a0406 captures the reportable event of stent material deformation inside the patient.Block h10: the returned tria soft ureteral stent was analyzed, and a visual evaluation noted that there was a torn in the first drainage hole.The suture and positioner was not returned for analysis.A functional inspection revealed that the stent pass through without resistance.In microscope magnification, the torn was observed closely.No other issues with the device were noted.The reported event was not confirmed.According to the product analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was possible to observe that the stent was manipulated, and it has the first drainage hole torn on bladder coil.It is important to mention that this kind of ureteral stent is assembled with their suture entries by the suture hole and exits on the first hole of drainage after the suture hole.Therefore, this failure could have been cause due to an interaction of the device with the suture string such during manipulation or excess of force applied during it use, causing the torn observed.According to the time of event, the retrieval line was cut during an ongoing procedure, meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the drainage hole torn.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a procedure in the ureter, performed on (b)(6) 2022.On (b)(6) 2022, a stent removal procedure was performed.When the physician removed the stent, it was noticed that the bladder pigtail was visually defective or deformed.Another tria ureteral stent was implanted in the patient and successfully completed the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: TRIA SOFT
• 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: 14502543
• Report Number: 3005099803-2022-02821
• Device Sequence Number: 12049771
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: 08714729959908
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 08/22/2024
• Device Model Number: M0061903230
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027890757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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