MAUDE Adverse Event Report: ASSUT EUROPE SPA OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	PU693IHBQ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code a0401 is being used to capture the reportable event of suture break.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used in an endoscopic sleeve gastroplasty procedure on (b)(6) 2024.The physician report that during the procedure the suture broke.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: boston scientific corporation does not have a regulatory/contractual obligation to report for this device.Assut europe spa owns all product approval, vigilance reporting, and post market surveillance responsibility.Therefore, this event was reported in error.With all the available information, boston scientific concludes that the most probable root cause assigned is known inherent risk of device.Overstitch 2-0 polypropylene suture is known and documented in the labeling and all reasonable steps have been taken.The returned suture was analyzed, and it was determined that the suture broke, for this reason the reported event was confirmed.Block h6: device code a0401 is being used to capture the reportable event of suture break.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used in an endoscopic sleeve gastroplasty procedure on (b)(6) 2024.The physician report that during the procedure the suture broke.There were no patient complications reported as a result of this event.

• Brand Name: OVERSTITCH 2-0 POLYPROPYLENE SUTURE
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ASSUT EUROPE SPA; zona industriale; magliano dei marsi 67062 ; IT 67062
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: arelene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20138481
• Report Number: 3005099803-2024-04261
• Device Sequence Number: 12633022
• Product Code: OCW
• UDI-Device Identifier: 18033439164295
• UDI-Public: 18033439164295
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 09/05/2025
• Device Model Number: PU693IHBQ
• Device Lot Number: 22SE1290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: Female