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

Model Number	M0061902210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code (b)(4).The returned tria urteral stent was analyzed, and a visual evaluation noted that the shaft middle section was detached.Additionally, under magnification it was observed around of the detachment struggle marks, no other issues (kinks or bends) were found in the device.The detached section, the suture string, and the positioner were not returned for the analysis.A functional evaluation noted that a mandrel 0.035" was loaded into the device and no resistance was felt.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, the part detached was missing.The suture string and the positioner were not returned with the device, it is evidence that the stent was manipulated out of the package.The problem of stent shaft middle section detached is a problem that could have been generated by the user or due to the interacting with other devices or an excess of force applied during the manipulation/handling of the device with the suture string.It is important to mention that during the product analysis under magnification it was possible to observed around the detached section marks of struggle and that could be generated with an incorrect manipulation of the suture string with 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 ureteral stent placement procedure in the urinary tract, performed on (b)(6) 2021.During unpacking, the stent came off when the suture was cut and tried to be pulled out.Another tria ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent shaft broken.

• 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: 12314498
• Report Number: 3005099803-2021-04139
• Device Sequence Number: 3839220
• Product Code: FAD
• UDI-Device Identifier: 08714729937838
• UDI-Public: 08714729937838
• 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
• Report Date (Section B): 08/12/2021

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: 09/04/2023
• Device Model Number: M0061902210
• Device Catalogue Number: 1983-01
• Device Lot Number: 0025970403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1