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

Model Number	M0061902240
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a tria firm ureteral stent was used during a transurethral lithotripsy procedure performed on (b)(6) 2022.During the procedure, when the physician took the stent out from the package, it was found that the coil part has been detached.The procedure was successfully completed with another tria firm ureteral stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent shaft detached, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).The returned tria firm ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail was detached and in the middle of the shaft.Their respective stabilizer was returned, however, there was no problem noted, and the suture returned loaded with a cut.The positioner was not returned.During the magnification, detachments were observed closely.Also, a functional inspection was performed, a mandrel of 0,039" and passed through stent without resistance.No other problem with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device media analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the device analysis performed, it was found that the device bladder coil was detached and shaft as well, and found that the suture was cut and unloading, indicating that there was a handle of the device.These issues could be caused by operational factors, interaction of the device with the suture string such as an entanglement during preparation of the device.It is possible that an excess of force applied to the suture string during the set up could damage it and cause the report issue.Consequently, affect the performance of the device.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15638353
• Report Number: 3005099803-2022-05914
• Device Sequence Number: 17562267
• Product Code: FAD
• UDI-Device Identifier: 08714729937869
• UDI-Public: 08714729937869
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 10/27/2024
• Device Model Number: M0061902240
• Device Catalogue Number: 1983-01
• Device Lot Number: 0028285758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2022
• Initial Report FDA Received Date: 10/20/2022
• Date Device Manufactured: 10/28/2021
• 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