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

Model Number	2578-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4 detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6 device code a0401 is being used to capture the reportable event of break.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty procedure on (b)(6), 2025.During the procedure, the suture broke.The procedure was completed using apollo branded sutures.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch suture was used during an endoscopic sleeve gastroplasty procedure on (b)(6) 2025.During the procedure, the suture broke.The procedure was completed using apollo branded sutures.There was no patient complications reported as a result of this event.According to additional information received on september 19, 2025 the procedure was delayed between 20 and 25 minutes.
Additional Manufacturer Narrative
Block h6.Device code a0401 is being used to capture the reportable event of break.Correction block h6: imdrf code f14 is added to capture the event of prolonged episode of care.Additional information block b5 updated based on information received on september 17, 2025.Block d4 updated based on information received on september 17, 2025.

• 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: 23000142
• Report Number: 3005099803-2025-04537
• Device Sequence Number: 21104687
• Product Code: OCW
• UDI-Device Identifier: 00191506060138
• UDI-Public: (01)00191506060138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 0036507641
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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