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	09/09/2025
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 x-tack device was used during a procedure on (b)(6) 2025.During the procedure, the cinch failed to deploy.The procedure was completed with an alternate device.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.Additional information: blocks a1, a2, a3a and a3b: updated based on additional information received on 08oct2025.Block h11.The returned suturing cinch was analyzed.A visual inspection was performed.The device was returned without the plug.During the visual inspection it was noted that the wire was broken in the proximal part of the handle and the working length was bent.It is not possible to confirm the reported event of cinch failure to deploy because the device was returned without the plug; therefore, it cannot be determined if the plug was removed or deployed.There is no objective evidence to establish if the wire break and the bent working length occurred before or after plug deployment.Based on all gathered information, the probable cause for the issues of cinch wire break and working length bent/kinked is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.The probable cause for the issue of cinch failure to deploy is cause not established because the analysis of the available information and product analysis did not determine a more specific complaint cause and it remains unknown the most probable causes that contributed to the event.All compiled information on this investigation determines that the most probable cause is "cause not established".
Event or Problem Description
It was reported to boston scientific corporation that an x-tack device was used during a procedure on (b)(6) 2025.During the procedure, the cinch failed to deploy.The procedure was completed with a new x-tack device.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: 23203054
• Report Number: 3005099803-2025-05066
• Device Sequence Number: 9278530
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)240319(17)270319(10)AF05960
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/21/2026

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: AF05960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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 Age: 73 YR
• Patient Sex: Female