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	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two overstitch 2-0 polypropylene suture used during the same procedure.It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during a procedure on (b)(6) 2025.During the procedure, the suture broke when it was time to cinch.The same issue happened with a second suture.The procedure was completed with a new overstitch suture.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.

• 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: 23862807
• Report Number: 3005099803-2025-06811
• Device Sequence Number: 15799368
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)241125(17)291125(10)24SE11815
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/22/2025

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: 24SE11815
• 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: 11/27/2025
• Initial Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 11/25/2024
• 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