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

Model Number	M0061902720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was in 70's.(b)(6).(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.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteral stent replacement procedure, performed on (b)(6) 2021.During the procedure, when the physician placed the stent, it was noticed that the stent was separated from the bladder pigtail section and remained inside the body of the patient.The bladder pigtail section was removed from the patient, but the remaining section of the stent remained inside the patient.Another tria ureteral stent was opened and successfully completed the procedure.The remaining section of the tria ureteral stent remains inside the patient and the patient has a plan for follow-up to remove the remaining section within the next few months.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was in 70's.Block e1: initial reporter state: (b)(6).Block h6: medical device problem code a0501 captures the reportable event of coil detached inside patient patient code e2008 captures the reportable event of unretrieved device fragments in patient.Impact code f23 captures the reportable event of the planned additional intervention to retrieve the remaining stent piece.Block h10: the returned tria ureteral stent was analyzed, and a visual evaluation noted that the stent was found detached.Only a 3 cm proximal tip of the detached section was retuned.The suture hole was found torn and the suture string was returned loaded and cut.No other problems issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that only the detached section, 3cm from the proximal tip, was returned.The suture hole was found torn and the suture string was returned loaded and cut in the part returned, evidence that the stent was manipulated.The physician might have cut the suture roughly, which might be led to stent break.After complaint device was broken, another of same device was additionally implanted.Adverse events associated with retrograde or antegrade positioned indwelling ureteral stents include but are not limited to pain/discomfort; stent fragmentation.Since the reported adverse events are known and documented in the labeling (including both short or long term known complications or adverse reactions) therefore, known inherent risk of device is selected as the most probable root cause for the complaint.Adverse event related to procedure is selected as the most probable root case for the suture hole torn and stent coil detachment.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h2: additional information: b5 based on information received on june 02, 2021.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteral stent replacement procedure, performed on (b)(6) 2021.During the procedure, when the physician placed the stent, it was noticed that the stent was separated from the bladder pigtail section and remained inside the body of the patient.The bladder pigtail section was removed from the patient, but the remaining section of the stent remained inside the patient.Another tria ureteral stent was opened and successfully completed the procedure.The remaining section of the tria ureteral stent remains inside the patient and the patient has a plan for follow-up to remove the remaining section within the next few months.The patient's condition at the conclusion of the procedure was reported to be stable.The remaining part of broken stent was removed from the patient body successfully at the week of (b)(6) 2021.

• Brand Name: TRIA FIRM
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11783712
• Report Number: 3005099803-2021-01992
• Device Sequence Number: 19747736
• Product Code: FAD
• UDI-Device Identifier: 08714729938132
• UDI-Public: 08714729938132
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 09/24/2023
• Device Model Number: M0061902720
• Device Catalogue Number: 1983-01
• Device Lot Number: 0026073788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR