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

Model Number	M0061903230
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a cystoscopy, removal of stent, retrograde pyelogram, ureteroscopy, laser lithotripsy, insertion of stent procedure in the kidney, ureter, and bladder, performed on (b)(6) 2021.Reportedly the tria ureteral stent was implanted on (b)(6) 2021.According to the complainant, the patient retuned to the emergency room on (b)(6) 2021.An unplanned stent removal was performed.It was noticed that the stent was obstructed and the kidney stone debris was unable to pass.The patient was diagnosed with hydronephrosis due to the obstructed stent.There was no treatment reported for the hydronephrosis.The physician removed the obstructed stent in its entirely and a new ureteral stent successfully completed the procedure.There were no additional patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good and successful.

• Brand Name: TRIA SOFT
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11276581
• Report Number: 3005099803-2021-00369
• Device Sequence Number: 14545907
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: 08714729959908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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 Expiration Date: 09/09/2023
• Device Model Number: M0061903230
• Device Catalogue Number: 1983-02
• Device Lot Number: 0025990009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention