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

Model Number M0061903230

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1050207 captures the reportable event of stent difficult to remove.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 323591932
• Report Number: 3005099803-2023-04831
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: 08714729959908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1