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	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of suture break.
Event or Problem Description
It was reported to boston scientific that a suture cinch was used in an esd procedure (b)(6) 2025.During the procedure, the esophageal stent was placed in the esophagus successfully.Multiple bites were taken with overstitch nxt and the t-tag was dropped so cinching could be completed with the suturing cinch.The technician loaded the suture through the suture cinch and the cinch was passed down the scope, over the suture.The technician extended the cinch out until the rings on the catheter were visible and applied minimal pressure to the suture.The technician was not able to deploy the cinch.It did not cut the suture and deploy no matter how hard they squeezed.Finally, they "snapped" the cinch and we used the appropriate bailout technique where the cinch's handle is snapped and they manually pull on the wire with a coker or instrument.This did not work either even with considerable pulling on the wire.Finally, the suture ended up giving way and the cinch pulled back into the scope and we were able to remove the scope from the patient.Upon examination, the peek plug was still attached to the end of the cinch and would not detach.The physician opted to not resuture, but rather just leave the esophageal stent in place and not anchor it with suture.The physician scoped back into the esophagus and no trauma was noted or bleeding.No patient complications were reported as a result of the event.The procedure was completed without the use of sutures.

• 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 ; IT
• Manufacturer Contact: arlene acevedo guierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21573337
• Report Number: 3005099803-2025-00930
• Device Sequence Number: 15641336
• Product Code: OCW
• UDI-Device Identifier: 10811955020732
• UDI-Public: 10811955020732
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: PLY-G02-020-APL
• Device Catalogue Number: PLY-G02-020-APL
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/11/2025
• 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