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

Model Number	M0061903230
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1050207 captures the reportable event of stent difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteroscopy procedure in the kidney/ureter performed on (b)(6), 2023.During the procedure, the physician spent more than thirty minutes attempting to retrieve a stent that had been pushed up into the kidney due to the marker on the pusher being invisible.The stent became knotted and was successfully removed from the patient.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteroscopy procedure in the kidney/ureter performed on (b)(6) 2023.During the procedure, the physician spent more than thirty minutes attempting to retrieve a stent that had been pushed up into the kidney due to the marker on the pusher being invisible.The stent became knotted and was successfully removed from the patient.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a1050207 captures the reportable event of stent difficult to remove.Block h10: the tria ureteral stent was not returned, however, there is one picture attached in the complaint record.The picture shows out of its original pouch, and it is observed the shaft torn, kinked and entangled, moreover, their suture and positioner are not visible.No other problems with the device were noted.Therefore, the reported complaint of difficult to view under fluoroscopy is not confirmed.The reported complaint of difficult to remove is confirmed.Taking all available information into consideration, 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 stent torn and kinked.Consequently, affect the performance of the device.For the reported problems of difficult to view under fluoroscopy, it was not confirmed since it was difficult to view under fluoroscopy and cannot be detected during the media analysis.For this reason, the as analyze code will be no problem detected.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 17761095
• Report Number: 3005099803-2023-04831
• Device Sequence Number: 6618280
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: 08714729959908
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 10/24/2023

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: 06/25/2026
• Device Model Number: M0061903230
• Device Catalogue Number: 1983-02
• Device Lot Number: 0031891498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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: Unknown