MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	2578-15
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty (esg) procedure on (b)(6) 2025.During the procedure, an undetermined number of sutures were reported to have snapped; however, the exact number could not be confirmed.The procedure was completed.There was no patient complications reported as a result of this event.Detailed information regarding the total number of sutures was not provided to bsc.We completed a good faith effort to obtain the information.If additional details become available, a supplemental report will be submitted.This is the second of two reports being submitted to cover the suture that looked frayed and the other sutures that broke.
Additional Manufacturer Narrative
Block h6: device code a0401 is being used to capture the reportable event of suture break.

• 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 ; 9145716918
• MDR Report Key: 24055274
• Report Number: 3005099803-2026-00185
• Device Sequence Number: 21337840
• Product Code: OCW
• UDI-Device Identifier: 00191506060138
• UDI-Public: (01)00191506060138(17)300917(10)37485292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: 2578-15
• Device Catalogue Number: 2578-15
• Device Lot Number: 0037485292
• 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: 12/17/2025
• Initial Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 09/18/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown