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

Model Number	M0061903240
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(4) 2021 based on the date the manufacturer became aware of the event.Medical device problem code a0401 captures the reportable event of stent shaft break.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.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a procedure.The event date is unknown.During preparation, the stent fell apart when the physician attempted to use it.The procedure was completed and it was unknown what model of stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to january 1, 2021 based on the date the manufacturer became aware of the event.Block h6: medical device problem 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 it was detached in bladder coil and it still having their suture load, however, it was cut.During a functional analysis use a mandrel of 0,039" and pass through stent without resistance finally caught their side ports of the renal coil stretched out.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, evidence found with the bladder coil detach and side port holes of renal coil stretch out.This is an issue that possible could be caused by operational factors, interaction of the device with the suture string such as an entanglement during preparation.It is possible that an excess of force applied to the suture string during the set up could damage it and cause the found issue.Consequently, affect the performance of the device.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.The event date is unknown.During preparation, the stent fell apart when the physician attempted to use it.The procedure was completed and it was unknown what model of stent was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 15099809
• Report Number: 3005099803-2022-03890
• Device Sequence Number: 19862573
• Product Code: FAD
• UDI-Device Identifier: 08714729959915
• UDI-Public: 08714729959915
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 09/28/2024
• Device Model Number: M0061903240
• Device Catalogue Number: 1983-02
• Device Lot Number: 0028112612
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown