MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-G02-NXT
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch nxt was used during a esg procedure performed on (b)(6) 2025.During the procedure, set up was fine and everything started smoothly with the first 'i' pattern, but then tissue got stuck inside the tower/needle driver, so essentially the device was stuck to the patient mucosa.We couldn't reload or even maneuver the scope.After trying multiple options to remove it, including use of a rat tooth and helix to try to help push the tissue away, we finally got the device free.However, shortly after that the suture prematurely dropped during the exchange.We dropped the suture, grabbed another and the same thing happened again.We already spent an extensive amount of time not suturing, so the thought was to grab another package and use a new anchor exchange catheter as that may be the problem.Thats when we discovered the needle driver was the issue and not aligning.This may have happened during the first complication when trying to remove it from mucosa.We ended up having to use overstitch sx since there was only one nxt on the shelf.Used a rat tooth and helix to try to help push the tissue away.No patient complications were reported as a result of this event.Procedure was completed with another of a similar device.
Additional Manufacturer Narrative
Block h6: imdrf code (b)(4) captures the reportable event of entrapment of device.Imdrf code f2301 captures the reportable event of additional device required.

• Brand Name: OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM
• 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): VIANT MEDICAL INC,; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21273492
• Report Number: 3005099803-2025-00106
• Device Sequence Number: 17096459
• Product Code: OCW
• UDI-Device Identifier: 10811955020893
• UDI-Public: 10811955020893
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K231553
• 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): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-NXT
• 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: 01/03/2025
• Initial Report FDA Received Date: 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown