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

Model Number	M00505410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 device code a04 is being used to capture the reportable event of suture stuck in the alignment tube.Imdrf code f2301 is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026.During the procedure, the suture became stuck in the alignment tube.Biopsy forceps were used to remove the suture from the alignment tube, and the procedure was completed with the original device.There was no patient complications reported as a result of this event.

• Brand Name: OverStitch Endoscopic Suture System
• 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: 50600380
• Report Number: 3005099803-2026-03577
• Device Sequence Number: 18818920
• Product Code: OCW
• UDI-Device Identifier: 00191506060091
• UDI-Public: (01)00191506060091(17)290217(10)38634141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/01/2026

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: M00505410
• Device Catalogue Number: M00505410
• Device Lot Number: 0038634141
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 02/18/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown