MAUDE Adverse Event Report: Apollo Endosurgery OverStitch Suture Cinch; Endoscopic Tissue Approximation Device

Model Number	CNH-G01-000
Medical Device Problem Codes	Mechanical Problem (1384); Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch and x-tack device were utilized during a defect closure procedure on (b)(6) 2026.During the procedure, the physician used an x-tack device to close the defect, successfully approximating all edges of the healthy tissue.The suture cinch was subsequently utilized; however, during cinch deployment, the suture cinch malfunctioned and severed the sutures while being tightened.As a result, all x-tack sutures broke, causing the tacks to disengage from the tissue.Consequently, the x-tack closure was lost due to the suture cinch malfunction.The patient experienced pain and discomfort and was admitted to the hospital beyond the expected standard of care.The procedure was successfully completed using a replacement device of the same type.
Additional Manufacturer Narrative
Block h6: imdrf code a150101 captures the reportable event of failure to deploy.Imdrf code f08 captures the reportable event of hospitalization or prolonged hospitalization.Investigation results summary: the suture cinch was not returned for analysis; therefore, a technical analysis could not be performed.The reported events could not be identified in the customer provided pictures.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.A labeling review was performed using the instructions for use (ifu).It was confirmed that the following reported events of discomfort and pain are anticipated in the ifu.There is no evidence the device was improperly used per the ifu.In reference to the event description, information and picture provided by the customer there is not enough evidence to determine whether the reported event of cinch failure to deploy was induced due to the physician's technique during the procedure or were related to a device malfunction.The as reported events of "additional device required" and "hospitalization or prolonged hospitalization required" occurred during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: christina lam ; 300 boston scientific way; marlborough,, MA 01752 ; EI 01752 ; 9145716918
• MDR Report Key: 25650403
• Report Number: 3005099803-2026-02602
• Device Sequence Number: 20300218
• Product Code: OCW
• UDI-Device Identifier: 20811955020678
• UDI-Public: (01)20811955020678(11)240819(17)270819(10)AF06124
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF06124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 129 LB