MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number	SBC-501
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0504 captures the reportable event of seal biopsy valve leak/splash.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2025.During plastic stent replacement, a sudden and forceful leakage of bile occurred from the seal biopsy valve.The procedure was completed using a different device.There were no patient complications reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; nolato contour inc; baldwin WI 54002
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22937544
• Report Number: 3005099803-2025-04356
• Device Sequence Number: 9783746
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• UDI-Public: (01)08714729981596
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182275
• 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
• Report Date (Section B): 09/02/2025

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: SBC-501
• Device Catalogue Number: SBC-501
• 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: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• 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