MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OverStitch Suture Cinch; Endoscopic Tissue Approximation Device

Model Number	M00505530
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a150101 captures the reportable event of failure to deploy.Imdrf code a0401 captures the reportable event of cinch wire break.
Event or Problem Description
It was reported that an overstitch nxt was used in the stomach during a fistula closure procedure on (b)(6) 2026.During the procedure, when attempting to deploy the cinch to secure the sutures, the cinch wire broke at the distal end of the catheter.Upon inspection, the cinch did not fully close and was unable to secure the two peek components together.The device could not complete the intended cinching function.An alternative closure method was attempted using x-tack, and a resolution 360 clip was subsequently used to successfully complete the procedure.There were no patient complications reported as a result of the event.

• Brand Name: OverStitch Suture Cinch
• Common Device Name: Endoscopic Tissue Approximation Device
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25334361
• Report Number: 3005099803-2026-02206
• Device Sequence Number: 21302580
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2026

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: M00505530
• Device Catalogue Number: M00505530
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/02/2026; 06/28/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/29/2026; 07/27/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-07142026-006-
• Patient Sequence Number: 1
• Patient Sex: Unknown