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
Additional Manufacturer Narrative
Block h6: device code a040103 captures the reportable event of a small piece of rubber sitting in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure on october 26, 2023 for the treatment of esophageal discomfort.During the procedure, once a biopsy forceps was passed, they found a small piece of rubber sitting in the esophagus.The dislodged piece was removed with a roth net.Upon inspection, it was noted that the foreign body was the inner ring of the biopsy cap that sheared off.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 h2: correction this event was previously reported under mfr report 3005099803-2023-06284.Any new event information will be sent under mfr report 3005099803-2023-06284.Block h6: device code a040103 captures the reportable event of a small piece of rubber sitting in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure on (b)(6) 2023 for the treatment of esophageal discomfort.During the procedure, once a biopsy forceps was passed, they found a small piece of rubber sitting in the esophagus.The dislodged piece was removed with a roth net.Upon inspection, it was noted that the foreign body was the inner ring of the biopsy cap that sheared off.The procedure was completed using the original seal biopsy valve.There was no patient complication 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; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18211723
• Report Number: 3005099803-2023-06321
• Device Sequence Number: 7373521
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

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: 11/03/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/26/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown