MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	M00509040
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150205 captures the reportable event of feeding tube difficult to advance.Imdrf patient code e2401 captures the reportable event of unspecified patient injury.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, it was reported that the surgeon could not get the device to slide or operate at all.The peg itself was not working properly causing the surgeon to request a new one.Additional clarification regarding the nature of the serious injury or the type of required intervention was not provided.No further information has been obtained despite good faith efforts.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 23566442
• Report Number: 3005099803-2025-05986
• Device Sequence Number: 18622987
• Product Code: PIF
• UDI-Device Identifier: 08714729880462
• UDI-Public: (01)08714729880462(17)260201(10)36080094
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 02/01/2026
• Device Model Number: M00509040
• Device Catalogue Number: M00509040
• Device Lot Number: 0036080094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 03/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown