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

Model Number	M00509071
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150205 captures the reportable event of feeding tube difficult to advance.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used in the stomach during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2025.During the procedure, when advancing the peg tube over wire, the plastic kinks when trying to push through incision site.A photo of the complaint device was provided and showed the insertion tube device with several kinks.To complete the procedure, the tract was dilated then the device was advance.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit push method was used in the stomach during a percutaneous endoscopic gastrostomy (peg) procedure performed on (b)(6) 2025.During the procedure, when advancing the peg tube over wire, the plastic kinks when trying to push through incision site.A photo of the complaint device was provided and showed the insertion tube device with several kinks.To complete the procedure, the tract was dilated then the device was advance.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150205 captures the reportable event of feeding tube difficult to advance.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: investigation results.The endovive standard peg kit push method device was not returned as it was reported to be implanted.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 insertion tube device has several kinks.No other problems with the device were noted.According to the media analysis performed, it was possible to observe that the insertion tube device has several kinks, however, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis, 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 STANDARD 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: 24027614
• Report Number: 3005099803-2026-00149
• Device Sequence Number: 8952477
• Product Code: PIF
• UDI-Device Identifier: 08714729880530
• UDI-Public: (01)08714729880530
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: M00509071
• Device Catalogue Number: 57706
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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