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

Model Number	M00505530
Medical Device Problem Codes	Break (1069); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that a suture cinch was utilized during a esophageal stent fixation procedure on (b)(6) 2026.During the procedure, a fully covered metal stent was placed, and an overstitch device was used to place the sutures.During the cinching process, the suture cinch handle broke and failed to cut the suture.The handle was intentionally broken, and a hemostat was used to pull the inner wire, allowing the cinch to be manually deployed and the suture to be released and cut.The procedure was completed using the original device without further complications.No patient complications were reported as a result of the event, and the patient fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf code a050702 captures the reportable event of failure to cut.Imdrf code f2301 captures the reportable event of additional device required.

• 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: 50050778
• Report Number: 3005099803-2026-03053
• Device Sequence Number: 21204964
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)290325(10)38939941
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• 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: 0038939941
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 03/26/2026
• 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