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

Model Number	M00509041
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: this event was reported by a boston scientific employee.The healthcare facility was not reported on the medwatch form and is unknown.Block h6: imdrf impact code f1901 captures the additional surgery performed to retrieve the broken tube.Imdrf device code a0501 captures the reportable event of feeding tube detached.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure performed on (b)(6) 2025.During the procedure, the tube broke while being pulled through the anterior abdominal wall.Part of the tube was left in the patient's stomach.A laparotomy was performed to retrieve the broken tube and placed a gastrostomy tube.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3 (date of event) and b5 have been corrected.Block e1: this event was reported by a boston scientific employee.The healthcare facility was not reported on the medwatch form and is unknown.Block h6: imdrf impact code f1901 captures the additional surgery performed to retrieve the broken tube.Imdrf device code a0501 captures the reportable event of feeding tube detached.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy tube placement procedure performed on (b)(6) 2025.During the procedure, the tube broke while being pulled through the anterior abdominal wall.Part of the tube was left in the patient's stomach.A laparotomy was performed to retrieve the broken tube and placed a gastrostomy tube.There were no reported patient complications as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21969567
• Report Number: 3005099803-2025-01923
• Device Sequence Number: 12827068
• Product Code: PIF
• UDI-Device Identifier: 08714729880479
• UDI-Public: (01)08714729880479(17)260201(10)35817254
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Expiration Date: 02/01/2026
• Device Model Number: M00509041
• Device Catalogue Number: M00509041
• Device Lot Number: 0035817254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 02/10/2025
• 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 Age: 22 YR
• Patient Sex: Unknown