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

Model Number	CNH-G01-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during a procedure on (b)(6) 2026.During the procedure, the cinch wire broke.The procedure was completed with a new cinch.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 the initial reporter's title is clinical research coordinator.Block h6 device code a0401 is being used to capture the reportable event of cinch wire break.Device evaluation: block h11.The suturing cinch was not returned for evaluation, and no media was provided for analysis.The reported event of cinch wire break could not be confirmed.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 wire break was due to the physician's technique during the procedure or was related to a device malfunction.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 24968319
• Report Number: 3005099803-2026-01481
• Device Sequence Number: 21439660
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)240628(17)270628(10)AF06030
• 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): 04/23/2026

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: AF06030
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 06/28/2024
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 105 KG