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

Model Number	M0061902220
Medical Device Problem Codes	Calcified (1077); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 2 months and was explanted on (b)(6) 2019, when the planned stent removal procedure was performed, the stent was found to have black discoloration.It was noticed that the stent was calcified around the bladder side and was occluded.Reportedly, the physician had to cut the bladder side of the stent with a cooper and a guidewire was inserted through the stent to remove the stent from the patient.Another tria ureteral stent was implanted and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Problem code and device code 1077 captures the reportable event of stent calcified.Problem code and device code 2423 captures the reportable event of stent obstruction of flow.Device returned and product aanalysis completed.A tria ureteral stent was returned for analysis.A visual evaluation of the returned device revealed that there was encrsustation/calcification outside and inside several locations of the stent.The stent returned with surface blackened at the proximal section.However, the lumen of the stent on the proximal and distal end does not look obstructed.A functional inspection was performed, mandrel 0.038" was inserted through the stent and not resistance was met during its advancing.Based on product analysis, the stent received with encrustation/calcification outside and inside at several locations and the directions for use states in the section of adverse events : "adverse events associated with retrograde or antegrade positioned indwelling ureteral stents include but are not limited to: occlusion/obstruction, encrustation, stone formation." there is no evidence that the device was not used in accordance with the dfu/label.Therefore, 'known inherent risk of device' is selected for the most probable cause for the complaint.A review of the device history record (dhr) confirmed that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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 2 months and was explanted on (b)(6) 2019, when the planned stent removal procedure was performed, the stent was found to have black discoloration.It was noticed that the stent was calcified around the bladder side and was occluded.Reportedly, the physician had to cut the bladder side of the stent with a cooper and a guidewire was inserted through the stent to remove the stent from the patient.Another tria ureteral stent was implanted and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects 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: 8857203
• Report Number: 3005099803-2019-03930
• Device Sequence Number: 2397269
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• 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,Followup
• Report Date (Section B): 10/09/2019

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: 02/17/2022
• Device Model Number: M0061902220
• Device Catalogue Number: 190222
• Device Lot Number: 0023362042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1