MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE JEJUNAL FEEDING TUBE; TUBE, FEEDING

Model Number	M00566320
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1409 captures the reportable event of a feeding tube obstruction.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that an endovive standard peg kit pull method and endovive jejunal feeding tube was used during a procedure performed on (b)(6) 2025.On (b)(6) 2025, a family member of the patient reported that the device had been obstructed since it was implanted and that the patient feeding was taking more than three hours without administration being completed.The tube was flushed with a 60 ml syringe before and after use, but a resistance was felt even during flushing.The tube was flushed three times, and the feeding regimen started over, but after three hours was not completed, which was considered as abnormal.No further information has been obtained despite good faith efforts.The family member stated that they had called an ambulance five times due to complications with the feeding tube however, no patient complications have been reported as a result of the event.

• Brand Name: ENDOVIVE JEJUNAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23537953
• Report Number: 3005099803-2025-06032
• Device Sequence Number: 13308733
• Product Code: FPD
• UDI-Device Identifier: 08714729786313
• UDI-Public: (01)08714729786313(17)260411(10)33805007
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/12/2025

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 Expiration Date: 04/11/2026
• Device Model Number: M00566320
• Device Catalogue Number: M00566320
• Device Lot Number: 0033805007
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 04/11/2024
• 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: Male