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

Model Number	M00505550
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a150101 is being used to capture the reportable event of cinch failure to deploy.Device evaluation block h11 the suturing cinch was not returned no media was available for analysis.Product analysis could not be performed.Due to the lack of evidence, the reported events of cinch failure to deploy and handle break 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 failure to deploy and handle break was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, "unable to exclude device problem" is selected as the most probable cause for this event.
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch - long was used during an endoscopic mucosal resection (emr) procedure on (b)(6) 2026.During the procedure, the fourth helix was stuck in the sheath and failed to deploy.The cinch also failed to deploy and the wire bent.It is unknown if the procedure was completed.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch - long was used during an endoscopic mucosal resection (emr) procedure on (b)(6) 2025.During the procedure, the fourth helix was stuck in the sheath and failed to deploy.The cinch also failed to deploy and the wire bent.It is unknown if the procedure was completed.No patient complications were 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.

• 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: 24493268
• Report Number: 3005099803-2026-00795
• Device Sequence Number: 10675871
• Product Code: OCW
• UDI-Device Identifier: 00191506049188
• UDI-Public: (01)00191506049188(17)280311(10)36054695
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00505550
• Device Catalogue Number: M00505550
• Device Lot Number: 0036054695
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 07/14/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/26/2026; 08/11/2026
• Date Device Manufactured: 03/12/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Male