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

Model Number	CNH-C01-213-L
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was returned to boston scientific that two suturing cinch was used in a fistula closure procedure on (b)(6) 2025.During the procedure, the physician first used argon to create a lesion similar to an ulcer and then used the x-tack device to close the lesion.The x-tack worked fine, but when the physician used the suturing cinch to cut the suture, the cinch did not knot the suture, and the suture came loose from the x-tack.Additional information received june 23, 2025 confirmed the cinch did not perform the mechanism it normally does to prevent the suture from becoming loose.This occurred with two suturing cinches.This record represents the first of two suturing cinches.The procedure was completed with another suturing cinch.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a150101 captures the reportable event of failure to deploy.

• 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: 22543698
• Report Number: 3005099803-2025-03407
• Device Sequence Number: 20586504
• Product Code: OCW
• UDI-Device Identifier: 20811955020753
• UDI-Public: (01)20811955020753(11)240103(17)270103(10)AF05845
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 07/18/2025

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: AF05845
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 01/03/2024
• 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