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	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used in the stomach during a stent fixation procedure on (b)(6) 2026.During the procedure, the cinch wire broke and as a result, they were unable to cut the suture.The cinch was successfully deployed with a hemostat.The procedure was completed with another of the same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a0401 is being used to capture the reportable event of cinch wire break.Device code a050702 is being used to capture the reportable event of cinch failure to cut.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11 device evaluation.The suturing cinch was not returned for evaluation, and there was no media available for analysis.The reported event could not be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on all gathered information, there is not enough evidence to determine whether the cinch wire break and cinch failure to cut was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, cause not established is selected as the most probable cause for this event.Additionally, for the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.For this reason, will be classified as cause not established.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is cause not established.

• 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: 25332557
• Report Number: 3005099803-2026-02192
• Device Sequence Number: 9907616
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)290302(10)38738005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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?: No
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 08/11/2026
• 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