MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH SUTURE CINCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	CNH-G01-000
Medical Device Problem Code	Activation Failure (3270)
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 the second of two overstitch suture cinch device used during the same procedure it was reported to boston scientific corporation that an overstitch suture cinch was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the procedure, the cinch failed to deploy.The same issue occurred with a second suture cinch device.The procedure was completed with another device from the same model.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a150101 is being used to capture the reportable event of cinch failure to deploy.

• Brand Name: OVERSTITCH SUTURE CINCH
• 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): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23863096
• Report Number: 3005099803-2025-06812
• Device Sequence Number: 9295031
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)240621(17)270621(10)AF06014
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181141
• 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: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF06014
• 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: 06/21/2024
• 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