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	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a suturing cinch was used in an esd procedure on (b)(6) 2025.When deploying a suturing cinch, there was a resistance, and it was impossible to use that cinch because the physician felt resistance and finally broke.No patient complications were reported as a result of the event.Procedure completed with an alternative device.
Additional Manufacturer Narrative
Block h6: imdrf code a150101 captures the reportable event of failure to deploy.
Additional Manufacturer Narrative
Block h6: imdrf code a150101 captures the reportable event of failure to deploy.Device analysis: the overstitch cinch was returned for analysis with the cinch loaded.No damages were found.The functional test related to the deployment of the cinch was performed by actuating the handle, the cinch was deployed, and no issues were found.Based on this information, the as reported code of cinch failure to deploy is unable to be confirmed because during the product analysis there was not objective evidence to confirm the reported failure.With all the available information, boston scientific concludes that the most probable cause assigned is no problem detected.
Event or Problem Description
It was reported to boston scientific that a suturing cinch was used in an esd procedure on (b)(6) 2025.When deploying a suturing cinch, there was a resistance, and it was impossible to use that cinch because the physician felt resistance and finally broke.No patient complications were reported as a result of the event.Procedure completed with an alternative device.

• 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: 21796664
• Report Number: 3005099803-2025-01446
• Device Sequence Number: 8230704
• Product Code: OCW
• UDI-Device Identifier: 20811955020753
• UDI-Public: (01)20811955020753(11)240531(17)270531(10)AF05995
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/25/2025

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: AF05995
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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