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

Model Number	M00505530
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture cinch was used during a per-oral plication of the esophagus procedure performed on (b)(6) 2026.It was reported that during the procedure, the last cinch failed to deploy.To troubleshoot the issue, the physician broke the device handle and used wire cutters to access the internal metal wire.The wire was wrapped around a kelly clamp multiple times and manually pulled, resulting in successful deployment of the cinch.The troubleshooting prolonged the procedure.Wire cutters and kelly clamps were used during the troubleshooting process to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a150101 is being used to capture the reportable event of cinch failure to deploy.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 suture cinch was used during a per-oral plication of the esophagus procedure performed on (b)(6) 2026.It was reported that during the procedure, the last cinch failed to deploy.To troubleshoot the issue, the physician broke the device handle and used wire cutters to access the internal metal wire.The wire was wrapped around a kelly clamp multiple times and manually pulled, resulting in successful deployment of the cinch.The troubleshooting prolonged the procedure.Wire cutters and kelly clamps were used during the troubleshooting process to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a150101 is being used to capture the reportable event of cinch failure to deploy.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11.Device evaluation.The device was not returned for analysis; therefore, a technical analysis could not be performed.The device media analysis included a picture where it can be observed the device into the pouch with the device label information.However, it is not possible identify any damages.For this reason, it is unable to confirm the reported events.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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on all gathered information, there is not enough evidence to determine whether the cinch failure to deploy was due to the physician's technique during the procedure or was related to a device malfunction.Additionally, for the event prolonged episode of care, additional device required and surgical intervention, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".In july 2026, boston scientific initiated a voluntary product removal associated with specific lots of the overstitch suture cinch (ref.(b)(4)).The referenced device was in scope of this product removal.

• 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: 25806680
• Report Number: 3005099803-2026-02790
• Device Sequence Number: 9054956
• Product Code: OCW
• UDI-Device Identifier: 00191506060046
• UDI-Public: (01)00191506060046(17)290325(10)38939941
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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: 0038939941
• 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: 06/16/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/10/2026
• 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