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

Model Number	CNH-C01-213-L
Medical Device Problem Codes	Break (1069); Failure to Cut (2587); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch - long was used during an endoscopic mucosal resection (emr) procedure on (b)(6) 2026.During the procedure, the cinch did not cut the suture or deploy, and the handle broke.The cinch was manually deployed to complete the procedure.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 code a050702 is being used to capture the reportable event of cinch failure to cut.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11 the suturing cinch was not returned.Product analysis could not be performed, for this reason and due to the lack of evidence it is unable to confirm the reported events.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 provided by the customer there is not enough evidence to determine whether the cinch failure to deploy, cinch failure to cut and handle break was due to the physician's technique during the procedure or was related to a device malfunction.For the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.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.All compiled information on this investigation determines that the most probable cause is "cause not established".

• Brand Name: SUTURE CINCH - LONG
• 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: 25444836
• Report Number: 3005099803-2026-02338
• Device Sequence Number: 12203492
• Product Code: OCW
• UDI-Device Identifier: 20811955020753
• UDI-Public: (01)20811955020753(11)231011(17)261011(10)AF05741
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNH-C01-213-L
• Device Catalogue Number: CNH-C01-213-L
• Device Lot Number: AF05741
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown