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	11/04/2025
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 gastric during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2025.During the procedure, while transferring the peg tub from inside the stomach outside of the stoma site.The nitinol wire that is attached to the peg tub, snapped.Thus, not allowing enough room to pull the tub out and having to remove the tub from the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of pull wire broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire broken.Block h11: investigation results.The endovive safety peg kit pull method device was not returned for analysis as it was reported to be disposed.Therefore, a technical analysis could not be performed.However, a media analysis was performed on the photo of the device provided by the complainant.The photo revealed that, the nitinol wire snapped.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of pull wire broken was confirmed.According to the photo provided by the customer the nitinol wire snapped.The investigation findings do not lead to a clear conclusion about the cause of the reported event.Therefore, the most probable cause of this complaint is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an endovive safety peg kit pull method was used in the gastric during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2025.During the procedure, while transferring the peg tub from inside the stomach outside of the stoma site.The nitinol wire that is attached to the peg tub, snapped.Thus, not allowing enough room to pull the tub out and having to remove the tub from the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 23697560
• Report Number: 3005099803-2025-06569
• Device Sequence Number: 13042473
• Product Code: PIF
• UDI-Device Identifier: 08714729880387
• UDI-Public: (01)08714729880387(17)260201(10)37298302
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/09/2026

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 Expiration Date: 02/01/2026
• Device Model Number: M00509000
• Device Catalogue Number: M00509000
• Device Lot Number: 0037298302
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 08/12/2025
• 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