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

Model Number	M0067201000
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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a single action pump was set to be used during a ureteroscopy (urs) procedure.During preparation, it was found that a hair was inside the packaging of the device.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.
Event or Problem Description
It was reported that a single action pump was set to be used during a ureteroscopy (urs) procedure.During preparation, it was found that a hair was inside the packaging of the device.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.Block h11: investigation results the product was not returned for analysis therefore technical analysis could not be performed; however, media analysis shows that the part of one pouch with a foreign matter.With all the available information, boston scientific concludes that the reported event of was confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the investigation results, the reported problem related to the presence of foreign material was considered confirmed.However, the device was not returned for evaluation.The return of the device would be necessary to verify the condition of the pouch and to determine the exact location of the reported foreign material within the product or packaging.Without the physical device available for further analysis, it is not possible to perform a detailed inspection to determine whether the foreign material originated from the device, packaging, or another external source.Although the reported event is considered confirmed based on the information provided, the investigation cannot trace the cause more specifically.Taking all available information into consideration an investigation conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation.

• 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: 24420864
• Report Number: 2124215-2026-09906
• Device Sequence Number: 5878347
• Product Code: KQT
• UDI-Device Identifier: 08714729752981
• UDI-Public: (01)08714729752981(17)291009(10)37673817
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: M0067201000
• Device Catalogue Number: 720-100S
• Device Lot Number: 0037673817
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/13/2026; 04/22/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/07/2026; 05/12/2026
• Date Device Manufactured: 10/10/2025
• 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