MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW; CATHETER, UROLOGICAL

Catalog Number	720-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/19/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific the study published in the international brazilian journal of urology aimed to identify perioperative predictors of immediate pain following ureteroscopy, with a specific focus on whether hydrodistention (from pressurized irrigation) of the renal collecting system contributes to post-procedure pain, where an irrigation syring unit was used.A total of 131 patients were included in the study who underwent ureteroscopy for stone treatment, with equal gender distribution.An unspecified amount of patient experienced pain that required narcotics upon post-anesthesia care unit.
Additional Manufacturer Narrative
Block b3: date of event: approximated to may 19, 2015, as to when the literature report was published.Block h6: patient code (b)(6) captures the reportable event of pain.Impact code f2303 captures the reportable event of medication required.Block g2 (report source): alazem, k., li, i., & monga, m.(20215).Predicting procedural pain after ureteroscopy: does hydrodistention play a role? journal of int braz j urol, 2016; 42: 734-9, https://doi.Org/10.1590/s1677-5538.Ibju.2015.0275.

• Brand Name: SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21194246
• Report Number: 2124215-2025-01479
• Device Sequence Number: 18027771
• Product Code: KOD
• UDI-Device Identifier: 08714729045076
• UDI-Public: 08714729045076
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K870557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 720-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown