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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used during an esd performed on (b)(6) 2024.A perforation was identified post procedure.The physician determined the perforation was caused by the esd procedure and not the use of the x-tack device.A laparoscopy was performed to resolve the perforation.The patient's condition at the conclusion of the procedure was reported to be stable and well.

• 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 SRL; alajuela, 02 MI 49504 ; CS 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19498262
• Report Number: 3005099803-2024-02759
• Device Sequence Number: 7925563
• Product Code: PKL
• UDI-Device Identifier: 20811955020760
• UDI-Public: 20811955020760
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: XTACK-160-H
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male