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	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (hemostats) to grab the broken wire.
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 performed on (b)(6) 2026.During the procedure, after the nurse completed the cut site, the physician advanced the wire and passed the pull wire through the peg tube as usual.The peg was then pulled down through the esophagus and into the stomach.When attempting to pull the peg through the gastric wall and into the stomach, the looped pull wire at the tip of the peg broke.Using hemostats, the team was able to grasp the broken pull wire at the tip of the peg and successfully complete placement.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.
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 performed on (b)(6) 2026.During the procedure, after the nurse completed the cut site, the physician advanced the wire and passed the pull wire through the peg tube as usual.The peg was then pulled down through the esophagus and into the stomach.When attempting to pull the peg through the gastric wall and into the stomach, the looped pull wire at the tip of the peg broke.Using hemostats, the team was able to grasp the broken pull wire at the tip of the peg and successfully complete placement.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop wire broken.Imdrf impact code f2301 captures the reportable event of additional device required (hemostats) to grab the broken wire.Block h11: investigation results: the device was not returned for analysis and was reported to be placed in the patient; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of loop break could not be confirmed.The device was not returned for analysis because it was implanted.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.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.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 ; 9145716918
• MDR Report Key: 24694408
• Report Number: 3005099803-2026-01104
• Device Sequence Number: 21343786
• Product Code: PIF
• UDI-Device Identifier: 08714729880387
• UDI-Public: (01)08714729880387(17)280531(10)38599471
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 04/27/2026

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 Model Number: M00509000
• Device Catalogue Number: M00509000
• Device Lot Number: 0038599471
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown