MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL

Model Number	M0067201010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a single action pump system was about to be used in a procedure.Reportedly, prior to procedure it was noted that a small contaminant was found inside.The device was not used in the patient, and the procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 08/01/2025 based on the date the manufacturer became aware of the event.Block h6: device code a1802 captures the reportable event of foreign matter.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 08/01/2025 based on the date the manufacturer became aware of the event.Block h6: device code a1802 captures the reportable event of foreign matter.Block h11: investigation results: the returned irrigation was analyzed, and a visual evaluation noted the device returned on its opened pouch and seals appears in good conditions.Microscopic examination was performed and it was noticed a foreign matter inside the pouch.With all the available information boston scientific conclude that the reported complaint was confirmed.Based on the analysis results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Additionally, a risk review found the issue reported as expected and detailed in the risk documentation.Therefore, an investigation conclusion code of manufacturing deficiency as the reported event was traced to the manufacturing process.
Event or Problem Description
It was reported that a single action pump system was about to be used in a procedure.Reportedly, prior to procedure it was noted that a small contaminant was found inside.The device was not used in the patient, and the procedure was completed with another of the same device with no patient complications.

• Brand Name: IRRIGATION
• 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: 23072406
• Report Number: 2124215-2025-64993
• Device Sequence Number: 4785936
• Product Code: KQT
• UDI-Device Identifier: 08714729752998
• UDI-Public: (01)08714729752998(17)290318(10)36099160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0036099160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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
• Patient Sex: Unknown