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

Model Number	M00505550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a suture cinch - long was used during an endoscopic sleeve gastroplasty (esg) procedure performed on (b)(6) 2026.During the procedure, the suture broke into 2 pieces off of the cinch catheter when applying tension before deploying.The procedure was completed with another suture cinch - long of the same model.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of suture break.Block h11 device evaluation: the device was not returned for analysis; therefore, a technical analysis could not be performed.For this reason and due to the lack of evidence is unable to confirm the reported event.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 the gathered information, there is not enough evidence to determine whether the reported event was due to the physician's technique during the procedure or was related to a device malfunction.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.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".

• 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: 50244674
• Report Number: 3005099803-2026-03312
• Device Sequence Number: 10378443
• Product Code: OCW
• UDI-Device Identifier: 00191506049188
• UDI-Public: (01)00191506049188(17)290624(10)39672414
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 0039672414
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 06/25/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown