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

Model Number	M0061902230
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.Initial reporter facility name: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation, therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted tria firm ureteral stent was being removed from a patient during a stent removal procedure in the bladder performed on (b)(6) 2020.The tria firm ureteral stent was implanted about two weeks prior to the planned stent removal procedure performed on (b)(6) 2020 with no issues reported during placement.However, the exact implant date was not reported.According to the complainant, on (b)(6) 2020, during the planned stent removal procedure, the stent was slipping from the grasper and it was difficult to remove.Reportedly, after several attempts the physician was able to remove the stent using a flexible grasper.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 10641251
• Report Number: 3005099803-2020-04431
• Device Sequence Number: 17056289
• Product Code: FAD
• UDI-Device Identifier: 08714729937852
• UDI-Public: 08714729937852
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: M0061902230
• Device Catalogue Number: 1983-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1