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

Model Number	M0061903220
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Vomiting (2144); Discomfort (2330); Urinary Incontinence (4572)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 07/01/2024, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 07/31/2024.Block h6: imdrf device code a010402 captures the reported event of stent migration.Imdrf impact code f08 captures the reported event of hospitalization.Imdrf impact code f1905 captures the reported event of device revision.
Event or Problem Description
It was reported that the previously implanted tria ureteral stent had migrated out of the urethra and the patient had experienced discomfort, flank pain, urinary incontinence, and vomiting.The migrated stent had to be removed and repositioned by the physician.No further patient complications were reported.
Event or Problem Description
It was reported that the previously implanted tria ureteral stent had migrated out of the urethra and the patient had experienced discomfort, flank pain, urinary incontinence, and vomiting.It was reported that post-procedure, the migrated stent had to be removed and repositioned by the physician.The stent was supposed to be placed in the patient for approximately 5 to seven days.No further patient complications were reported.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 07/01/2024, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 07/31/2024.Block h6: imdrf device code a010402 captures the reported event of stent migration.Imdrf impact code f08 captures the reported event of hospitalization.Imdrf impact code f1905 captures the reported event of device revision.Block h11: updated field block b5: describe event or problem.Correction to field block e1: initial reporter facility name.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20085988
• Report Number: 2124215-2024-53018
• Device Sequence Number: 7562193
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/27/2024

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 Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0033519626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/27/2024
• Date Device Manufactured: 02/28/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown