MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	PLY-G02-020-APL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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 during a pancreatic fistula closure procedure on (b)(6) 2026.During the procedure, the suture broke after it was connected to the device.The procedure was completed with a new suture.There was no patient complications 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.Device evaluation: block h11: the overstitch suture was not returned for evaluation, and no media was available for analysis.The reported event of suture break could not be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on all gathered information, the probable cause selected is cause not established, because 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.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used during a pancreatic fistula closure procedure on (b)(6) 2026.During the procedure, the suture broke after it was connected to the device.The procedure was completed with a new suture.There was 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 ; 9145716918
• MDR Report Key: 24579005
• Report Number: 3005099803-2026-00919
• Device Sequence Number: 13069544
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: (01)10811955020732(11)240923(17)290925(10)24SE09494
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K191439
• 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): 04/16/2026

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: 24SE09494
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 09/23/2024
• 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