MAUDE Adverse Event Report: Apollo Endosurgery OverStitch 2-0 Polypropylene Suture; Endoscopic Tissue Approximation Device

Model Number	PLY-G02-020-APL
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code (b)(4) is being used to capture the reportable event of anchor bent.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was intended to be used to treat obesity during an endoscopic sleeve gastroplasty (esg) procedure performed on (b)(6) 2026.During preparation, there was difficulty loading the needle into the needle holder/needle shaft.Multiple attempts to load the needle were unsuccessful.Visual inspection revealed an apparent deformed area at the proximal section of the needle where it interfaces with the needle shaft.The procedure was completed with another overstitch 2-0 suture of the same model.The patient fully recovered following the procedure, and 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): Apollo Endosurgery; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): ASSUT EUROPE SPA; via giuseppe gregoraci 12; rome, rm, 00137 ; IT 00137
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25821006
• Report Number: 3005099803-2026-02814
• Device Sequence Number: 13363580
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)241209(17)291209(10)24SE12529
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K191439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: PLY-G02-020-APL
• Device Catalogue Number: PLY-G02-020-APL
• Device Lot Number: 24SE12529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 12/09/2024
• 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