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

Model Number	M00505430
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6)2026.During the procedure, the cap began to slip off of the endoscope.The physician cinched the suture earlier than originally planned.The procedure was completed with another overstitch nxt.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 is being used to capture the reportable event of cap detachment.

• Brand Name: OverStitch NXT Endoscopic Suturing 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: 50785488
• Report Number: 3005099803-2026-03796
• Device Sequence Number: 16094818
• Product Code: OCW
• UDI-Device Identifier: 00191506060107
• UDI-Public: (01)00191506060107
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K231553
• 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): 09/16/2026

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: M00505430
• Device Catalogue Number: M00505430
• Device Lot Number: 0039484220
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/03/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown