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	05/01/2025
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 attempted to be used in the stomach during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2025.The specific date is unknown.During the procedure, the physician placed a peg tube and the wire loop (while attached to the peg tube) completely snapped off when the physician was trying to pull the peg tube through the incision.The physician attempted to use a hemostat to pull the part of the tube still coming out of the patient and the rest of the wire broke off.A photo of the complaint device was provided and showed that the loop wire was broken and was detached from the connecting wire.It was reported that no part of the device detached inside the patient.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 b3: approximated based on the reported event date of (b)(6) 2025.Block h6: imdrf device code a0401 captures the reportable event of loop wire break.Imdrf device code a0401 captures the reportable event of pull wire break.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22719719
• Report Number: 3005099803-2025-03691
• Device Sequence Number: 9206832
• Product Code: PIF
• UDI-Device Identifier: 08714729880424
• UDI-Public: (01)08714729880424(17)250831(10)35882385
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/05/2025

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: 08/31/2025
• Device Model Number: M00509020
• Device Catalogue Number: M00509020
• Device Lot Number: 0035882385
• 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: 07/09/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 08/18/2022
• 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