MAUDE Adverse Event Report: APOLLO ENDOSURGERY X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM); HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	XTACK-160-H
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an x-tack was used in the stomach for treatment of a gastric ulcer in the incisura during an esophagogastroduodenoscopy (egd) with closure procedure on (b)(6) 2025.During the procedure, the endoscope was passed into the stomach to close a gastric ulcer in the stomach incisura.Four helix tacks were placed.When the physician pulled the suture to approximate the defect, the suture was caught in the system and could not be pulled to approximate the defect.The suture was cut and removed.The procedure was completed with another x-tack.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a0406 captures the reportable event of suture tangled.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM)
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22348865
• Report Number: 3005099803-2025-02950
• Device Sequence Number: 8639034
• Product Code: PKL
• UDI-Device Identifier: 20811955020760
• UDI-Public: (01)20811955020760(11)230531(17)260530(10)AF05577
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201808
• 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): 06/27/2025

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: 05/30/2026
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF05577
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 05/31/2023
• 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