MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OverStitch 2-0 Polypropylene Suture; Endoscopic Tissue Approximation Device

Model Number	M00505451
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used in the stomach during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.During the procedure, the physician was placing a u-stitch suture pattern when two sutures broke in the middle of the suture material rather than detaching from the anchor.The first affected suture was removed from use and replaced with a new device; however, the issue recurred with a second suture, requiring another replacement device to be opened.Approximately 10 minutes were required each time to cut and remove the broken suture, resulting in an estimated 20-minute procedure prolongation.The procedure was ultimately completed using another of the same device from a different lot.During the procedure, the patient developed a hematoma located in the body of the stomach between the greater and lesser curvature.No additional intervention was performed to treat the hematoma; the physician sutured around the affected area and completed the procedure.The physician was unable to determine whether the device or the procedure caused or contributed to the hematoma.The patient was not admitted beyond the standard of care, subsequently recovered, and was discharged home.This is the second of two overstitch sutures used in the same procedure.
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of suture break.

• Brand Name: OverStitch 2-0 Polypropylene Suture
• 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: 25524911
• Report Number: 3005099803-2026-02494
• Device Sequence Number: 21519243
• Product Code: OCW
• UDI-Device Identifier: 00191506060138
• UDI-Public: (01)00191506060138(17)301001(10)37603787
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: M00505451
• Device Catalogue Number: M00505451
• Device Lot Number: 0037603787
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2026
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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