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

Model Number	M00509020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used in the stomach during a percutaneous endoscopic gastrostomy (peg) placement procedure to provide nutritional support performed on (b)(6) 2025.During the procedure, the wire broke during pull portion.A photo of the complaint device was provided and showed that the pull wire was broken.The procedure was completed with another endovive safety peg kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used in the stomach during a percutaneous endoscopic gastrostomy (peg) placement procedure to provide nutritional support performed on (b)(6) 2025.During the procedure, the wire broke during pull portion.A photo of the complaint device was provided and showed that the pull wire was broken.The procedure was completed with another endovive safety peg kit pull method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: investigation results: the endovive safety peg kit pull method device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the pull wire was broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported events of pull wire break was confirmed.According to the media analysis performed, it was possible to observe that the pull wire was broken, however, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.

• Brand Name: ENDOVIVE SAFETY 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: 23473070
• Report Number: 3005099803-2025-05845
• Device Sequence Number: 18781241
• Product Code: PIF
• UDI-Device Identifier: 08714729880424
• UDI-Public: (01)08714729880424(17)260201(10)37188748
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 02/01/2026
• Device Model Number: M00509020
• Device Catalogue Number: M00509020
• Device Lot Number: 0037188748
• 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
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 06/09/2025
• 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