MAUDE Adverse Event Report: APOLLO ENDOSURGERY X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM); HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	XTACK-235-H
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the first tack was placed and when removing catheter to load second tack, the first tack pulled out of the tissue.The physician felt tension when removing catheter and thinks the system was jammed up or twisted.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a0406 captures the reportable event of tangled.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM)
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20171464
• Report Number: 3005099803-2024-04396
• Device Sequence Number: 8070264
• Product Code: PKL
• UDI-Device Identifier: 20811955020777
• UDI-Public: 20811955020777
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/09/2024

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-235-H
• Device Lot Number: AF05575
• 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: 08/19/2024
• Initial Report FDA Received Date: 09/09/2024
• Date Device Manufactured: 05/30/2023
• 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