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

Model Number	CNH-G01-000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); 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.During the visual inspection it was observed that the device was returned with the wire break and outside of the device with the plug attached.For this reason, there is enough evidence to confirm the reported event of cinch failure to deploy.Most likely, procedural factors such as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.For this reason, this event is catalogued as "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on event.The identification of a broken wire within the device provides a direct causal explanation for the adverse event observed, specifically the "cinch failure to deploy".The wire break disrupted the transmission of mechanical force required for the deploy function, confirming that the wire failure was the primary root cause of the procedural complications.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.
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.

• 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: 23203041
• Report Number: 3005099803-2025-05067
• Device Sequence Number: 13042141
• 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 Sex: Unknown