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

Model Number	M00505530
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of cinch wire break.Imdrf code a150101 captures the reportable event of failure to deploy.Imdrf code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch was utilized in an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026, for the treatment of obesity.During the 5th suture during the procedure, the tech fired as normal, but the inner cinch wire broke.The tech had to use a hemostat to grab the inner wire and fire manually resulting in successful deployment.The procedure was completed with the original device.No patient complications were reported as a result of the event.The complainant reported that the territory manager observed the technician removing the safety and holding the handle open while the physician tightened the suture, rather than waiting until the suture was tightened to remove the safety and fire the device in one continuous motion.However, according to the instructions for use (ifu), "remove the safety spacer from the cinch handle while maintaining suture tension.".

• 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: 25314147
• Report Number: 3005099803-2026-02169
• Device Sequence Number: 16080167
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)290302(10)38738005
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/11/2026

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: M00505530
• Device Catalogue Number: M00505530
• Device Lot Number: 0038738005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/25/2026
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/29/2026; 07/31/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/28/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2026
• 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: 3005099803-07142026-006R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown