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	Wound Dehiscence (1154)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event estimate 01feb2025.Block h6: imdrf code e2340 captures the reportable event of wound dehiscence.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system (160cm) was used during an unknown procedure type performed on an unknown date.During the procedure, the x-tack endoscopic helix tacking system system performance was dissatisfactory in relation to closure.The physician advised that he had experienced two serious post complications of leaks after closure with x-tack.No information has been provided to date on how the leaks were treated or if they were treated.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system (160cm) was used during an unknown procedure type performed on an unknown date.During the procedure, the x-tack endoscopic helix tacking system system performance was dissatisfactory in relation to closure.The physician advised that he had experienced two serious post complications of leaks after closure with x-tack.No information has been provided to date despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event estimate 01feb2025.Block h6: imdrf code e2340 captures the reportable event of wound dehiscence.

• 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 78746 ; CS 78746
• Manufacturer Contact: armelle acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21503678
• Report Number: 3005099803-2025-00762
• Device Sequence Number: 4591226
• 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,Followup
• Report Date (Section B): 03/06/2025

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?: 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/06/2025
• 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