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

Model Number	CNH-C01-213-L
Medical Device Problem Codes	Failure to Cut (2587); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a050702 captures the reportable event of failure to cut.Imdrf code a150101 captures the reportable event of failure to deploy.
Event or Problem Description
It was reported to boston scientific that a suturing cinch was used in the esophagus during a fistula closure procedure on (b)(6) 2025.During the procedure, the cinch did not release correctly as it did not cut the thread.The procedure was completed with another suturing cinch.No patient complications were reported as a result of the event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22436303
• Report Number: 3005099803-2025-03216
• Device Sequence Number: 19621119
• Product Code: OCW
• UDI-Device Identifier: 20811955020753
• UDI-Public: (01)20811955020753(11)240812(17)270812(10)AF06109
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201808
• 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): 07/08/2025

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-C01-213-L
• Device Catalogue Number: CNH-C01-213-L
• Device Lot Number: AF06109
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 08/12/2024
• 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: 78 YR
• Patient Sex: Female