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

Model Number	M0061903220
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a tria soft ureteral stent was used during a ureteroscopy laser lithotripsy procedure in the urinary system performed on (b)(6) 2023.During the procedure, it was noticed that the coil part of the stent was bent.The coil part was detached during the process, but it had already been bent before it was put into use.The broken coil of the stent was successfully retrieved using a grasper and the procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detached, inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detached, inside the patient.Block h11: correction to block b1, adverse event/product problem field has been updated.
Event or Problem Description
It was reported to boston scientific that a tria soft ureteral stent was used during a ureteroscopy laser lithotripsy procedure in the urinary system performed on (b)(6), 2023.During the procedure, it was noticed that the coil part of the stent was bent.The coil part was detached during the process, but it had already been bent before it was put into use.The broken coil of the stent was successfully retrieved using a grasper and the procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.Additional information received on 06sep2023, confirming that they actually did not use a grasper.

• 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: 17592146
• Report Number: 3005099803-2023-04272
• Device Sequence Number: 6284128
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2025
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0030708931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown