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

Model Number	720-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a single action pump was used during a cystourethroscopy with ureteroscopy; with treatment of ureteral stricture procedure performed on (b)(6) 2017, to treat a patient with calculus of ureter.During the procedure, the patient's ureter was lacerated.The patient was discharged one (1) day post-procedure.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of(b)(6) 2017, was chosen as the best estimate based on the admission date.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e2009 captures the reportable event of ureter laceration.Impact code f08 captures the reportable event of prolonged hospitalization.Impact code f2303 captures the reportable event of medication required.

• Brand Name: SINGLE ACTION PUMPING SYSTEM
• 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 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19593948
• Report Number: 2124215-2024-38132
• Device Sequence Number: 4160376
• Product Code: KOD
• UDI-Device Identifier: 08714729045069
• UDI-Public: 08714729045069
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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 Model Number: 720-100
• Device Catalogue Number: 720-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/24/2024
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White