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

Model Number	M00505550
Medical Device Problem Codes	Break (1069); Failure to Cut (2587); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that a suture cinch was utilized during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2026 for the treatment of obesity.During the procedure, the suture cinch handle did not deploy the cinch.The staff attempted to manually break the handle to manually deploy it however it did not work, the cinch did not cut the suture.The procedure was completed with another of the same device.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a050702 captures the reportable event of failure to cut imdrf code a150101 captures the reportable event of failure to deploy imdrf code f2301 captures the reportable event of additional device required.

• Brand Name: Suture Cinch - Long
• 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: 50003540
• Report Number: 3005099803-2026-03043
• Device Sequence Number: 18737573
• Product Code: OCW
• UDI-Device Identifier: 00191506049188
• UDI-Public: (01)00191506049188(17)280930(10)37586915
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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: M00505550
• Device Catalogue Number: M00505550
• Device Lot Number: 0037586915
• 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; Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/10/2026; 09/04/2026
• Date Device Manufactured: 10/01/2025
• 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
• 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