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

Model Number	SBC-501-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used in initial examination on esophagus, stomach, and duodenum during an esophagogastroduodenoscopy (egd) procedure on (b)(6) 2023.During the procedure, the center portion of the valve fell into the patient.The valve was removed using roth net and the procedure was completed using the original seal biopsy valve.There were no patient complication as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a040103 captures the reportable event of biopsy valve fell into the patient.

• 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; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18211711
• Report Number: 3005099803-2023-06284
• Device Sequence Number: 7372999
• Product Code: OCX
• UDI-Device Identifier: 08714729981619
• UDI-Public: 08714729981619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Model Number: SBC-501-100
• Device Catalogue Number: 2235-01
• Device Lot Number: 0018602008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 68 KG