MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROVAC BLADDER EVACUATOR; EVACUATOR, BLADDER, MANUALLY OPERATED

Model Number	M0067301251
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a urovac device was about to be used during turp (transurethral resection of the prostate) procedure.Reportedly, upon opening the packaging they saw a black flecks inside 3 urovacs.The procedure was completed with another of the same device with no patient complications.This report pertains to the first of three urovac devices used in the same procedure.
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of foreign material present in the device.

• Brand Name: UROVAC BLADDER EVACUATOR
• Common Device Name: EVACUATOR, BLADDER, MANUALLY OPERATED
• 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: 21961805
• Report Number: 2124215-2025-28558
• Device Sequence Number: 18454734
• Product Code: FFD
• UDI-Device Identifier: 08714729033769
• UDI-Public: (01)08714729033769(17)290223(10)35954603
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/05/2025

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: M0067301251
• Device Catalogue Number: 730-125
• Device Lot Number: 0035954603
• 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: 04/09/2025
• Initial Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 02/24/2025
• 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