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

Model Number	CNH-G01-000
Medical Device Problem Codes	Material Integrity Problem (2978); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a150101 is being used to capture the reportable event of cinch failure to deploy.
Event or Problem Description
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, it was observed that the cinch plug was bent and therefore could not deploy.The procedure was completed with a new cinch.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.Device evaluation.Block h11.The suturing cinch was not returned for analysis.A media analysis was performed.The documentation attached includes some pictures where it can be observed the device label information with the batch and upn number, additionally it can be observed in another picture the device.However not is possible identify any damages.The reported event of cinch failure to deploy could not be confirmed.A risk review of the suturing cinch was completed and confirmed that the event of cinch failure to deploy was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on all gathered information, there is not enough evidence to determine whether the cinch failure to deploy and cinch damaged/defective was due to the physician's technique during the procedure or was related to a device malfunction.Due to lack of evidence and without proper evaluation of the device, this investigation is assigned a most probable conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during an esg procedure on (b)(6) 2025.During the procedure, it was observed that the cinch plug was bent and therefore could not deploy.The procedure was completed with a new cinch.There was no patient complications reported as a result of this event.

• 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: 23495938
• Report Number: 3005099803-2025-05895
• Device Sequence Number: 8911218
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)241019(17)271019(10)AF06296
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF06296
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 10/19/2024
• 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