MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROVAC BLADDER EVACUATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0067301250
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	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.
Event or Problem Description
It was reported that a urovac bladder evacuator device was set to be use during a procedure.Reportedly, it was noticed that a hair was found inside of the sterile packaging.No patient involvement or harm occurred.
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.Block h11: investigation results the returned urovac was analyzed, and a visual evaluation noted that a foreign matter was inside the opened pouch.It was also noted that the pouch had already been opened which indicates that the pouch integrity was compromised.With all the available information, boston scientific concludes that the reported event was not confirmed since the foreign matter could have entered after opening.Due to the open condition of the packaging, it is not possible to determine whether the foreign matter was present inside the pouch at the time the product left the company or if it was introduced after distribution.Additionally, the investigation findings did not lead to a clear conclusion about the most probable cause of the reported event.During manufacturing process, product builders are trained to perform cosmetic inspections to ensure the integrity of the device that would have captured the encountered problem.Therefore, based on the information available and analysis results an investigation conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that a urovac bladder evacuator device was set to be use during a procedure.Reportedly, it was noticed that a hair was found inside of the sterile packaging.No patient involvement or harm occurred.

• Brand Name: UROVAC BLADDER EVACUATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• 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: 23616187
• Report Number: 2124215-2025-85106
• Device Sequence Number: 10045275
• Product Code: KQT
• UDI-Device Identifier: 08714729753018
• UDI-Public: (01)08714729753018(17)290903(10)37374219
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K880099
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: M0067301250
• Device Catalogue Number: 730-125S
• Device Lot Number: 0037374219
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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