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

Model Number	M0061902420
Medical Device Problem Codes	Calcified (1077); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
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 previously implanted tria ureteral stent was used removed from a patient during ureteral stent removal procedure performed in the ureter on (b)(6) 2019.The exact implant date was not provided.According to the complainant, the stent was implanted for 10 weeks and was explanted on (b)(6) 2019, when the planned stent removal procedure was performed due to the periodic replacement, the stent was found to have black discoloration in the bladder side and kidney.It was noticed that the stent was calcified around the bladder side and was occluded, however the stent was able to drain.Reportedly, the physician had to cut the bladder side of the stent and used forceps to remove the stent from the patient.The procedure was completed with non bsc product.There were no patient complications reported as a result of this event.

• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8789854
• Report Number: 3005099803-2019-03612
• Device Sequence Number: 2666879
• Product Code: FAD
• UDI-Device Identifier: 08714729937968
• UDI-Public: 08714729937968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 01/22/2022
• Device Model Number: M0061902420
• Device Catalogue Number: 190242
• Device Lot Number: 0023233251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1