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

Model Number	M0061902220
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that, during unpacking, the seal of the tria ureteral stent packaging was torn.
Event or Problem Description
It was reported that, during unpacking, the seal of the tria ureteral stent packaging was torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: the returned tria ureteral stent was analyzed, and a visual evaluation noted that the blue closure strip was peeled off with a foreign matter on the adhesive strip.Also, the bottom of the box was found with the label torn.No other problem with the device were noted.The reported event was confirmed.Based on the product analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Regarding to the analysis, it was confirmed that there is enough evidence to demonstrate the device left the production floor being acceptable and fully functional.There are some controls for the process to ensure that there is no damage to the closure strip.Therefore, based on the information gathered, the most probable cause of the reported issue cannot be established since the investigation findings do not lead to a clear conclusion, about the cause of the reported adverse event, cause not established was selected as the most probable cause for the complaint.

• Brand Name: TRIA FIRM
• 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: 19697495
• Report Number: 2124215-2024-40257
• Device Sequence Number: 17066585
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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 Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Device Lot Number: 0033461796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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
• Patient Sex: Unknown