MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EndoVive Safety PEG Kit; gastrointestinal tubes with enteral specific connectors

Model Number	M00509000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
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 upper gi tract during an esophagogastroduodenoscopy (egd) with placement of a peg procedure to treat cancer performed on (b)(6) 2026.During the procedure, there was a pull peg being place on a patient as they were passing the peg portion and pulling it through the patient, the metal cable snapped/sheered.Luckly there was small portion of the bed that came out of the opening in the stomach that allowed the doctor to fully pull it through.The procedure was completed with the same original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used in the upper gi tract during an esophagogastroduodenoscopy (egd) with placement of a peg procedure to treat cancer performed on (b)(6) 2026.During the procedure, there was a pull peg being place on a patient as they were passing the peg portion and pulling it through the patient, the metal cable snapped/sheered.Luckily there was small portion of the bed that came out of the opening in the stomach that allowed the doctor to fully pull it through.The procedure was completed with the same original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on (b)(6) 2026: it was reported that a small portion of the peg came through the opening that was made in the stomach for the peg and they were able to pull it through and finish the case.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Additional Manufacturer Narrative
Block h2: block b5 has been updated based on additional information received 28 aug 2026.Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: investigation results the device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50423134
• Report Number: 3005099803-2026-03468
• Device Sequence Number: 10417898
• Product Code: PIF
• UDI-Device Identifier: 08714729880387
• UDI-Public: (01)08714729880387(17)280531(10)38628953
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Model Number: M00509000
• Device Catalogue Number: M00509000
• Device Lot Number: 0038628953
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 05/01/2025
• 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