MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	PLY-G02-020-APL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a0401 is being used to capture the reportable event of suture break.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during a fistula closure procedure on (b)(6) 2025.During the procedure, the suture snapped.The procedure was completed using the original method.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a0401 is being used to capture the reportable event of suture break.Additional information b5: according to information received on september 30, 2025, the anatomical location of the procedure was the stomach.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during a stomach fistula closure procedure on (b)(6) 2025.During the procedure, the suture snapped.The procedure was completed using the original method.There was no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH 2-0 POLYPROPYLENE SUTURE
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): ASSUT EUROPE SPA; via giuseppe gregoraci 12; rome, rm 00137 ; IT 00137
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22868452
• Report Number: 3005099803-2025-04062
• Device Sequence Number: 15366314
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)240715(17)290715(10)24SE7500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: PLY-G02-020-APL
• Device Catalogue Number: PLY-G02-020-APL
• Device Lot Number: 24SE7500
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 07/15/2024
• 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