MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OverStitch 2-0 Polypropylene Suture; Endoscopic Tissue Approximation Device

Model Number	M00505451
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 an overstitch 2-0 polypropylene suture was used to treat obesity during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2026.During the procedure, the device exhibited a condition where the suture snapped when removing slack.The procedure was completed with another device of the same model.The patient is stable following the procedure, and there were no problems reported as a result of this event.
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 disposed by customer; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Boston scientific concludes that, given the event description and information provided by the customer there is not enough evidence to determine whether the suture break was due to the physician's technique during the procedure or was related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: OverStitch 2-0 Polypropylene Suture
• 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: 50287282
• Report Number: 3005099803-2026-03360
• Device Sequence Number: 9694393
• Product Code: OCW
• UDI-Device Identifier: 00191506060138
• UDI-Public: (01)00191506060138(17)310108(10)38310227
• 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): 09/22/2026

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: M00505451
• Device Catalogue Number: M00505451
• Device Lot Number: 0038310227
• 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: 08/26/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 01/09/2026
• 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