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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.During the procedure, while attempting to deploy the cinch, the suture was cut but the cinch remained attached to the wire and handle.The procedure was completed with the original device using forceps to separate the cinch from the wire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a0401 is being used to capture the reportable event of cinch wire break.
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of cinch wire break.Block h11: the device was not returned for analysis.The customer provided a photo of the label and a video of the procedure; however, the evidence was limited and did not offer additional details to support the analysis.The reported cinch wire break could not be confirmed.The most probable cause remains unknown, as it cannot be determined without a proper evaluation of the device.A review of the product labeling confirmed that the device was used according to the directions for use (dfu).
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6), 2025.During the procedure, while attempting to deploy the cinch, the suture was cut but the cinch remained attached to the wire and handle.The procedure was completed using an alternate device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.Based on additional information received on (b)(6), 2025.The handle and the outer sheet sperate from the cinch wire, the procedure was completed with the original device using forceps to separate the cinch from the wire.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22543723
• Report Number: 3005099803-2025-03296
• Device Sequence Number: 8468299
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)231013(17)261013(10)AF05746
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 08/14/2025

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-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF05746
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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
• Patient Sex: Unknown