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	Break (1069); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a x-tack endoscopic helix tacking system was used during a fistula closure procedure performed on (b)(6) 2024.During the procedure, the x-tack was difficult to release from the catheter.During deployment, the x-tack handle broke causing difficulty in removing the x-tack catheter.The procedure was aborted.There were no patient complications reported as a result of this event.

• 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: 19258915
• Report Number: 3005099803-2024-01925
• Device Sequence Number: 16789708
• Product Code: PKL
• UDI-Device Identifier: 20811955020777
• UDI-Public: 20811955020777
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/07/2024

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 Model Number: XTACK-235-H
• Device Lot Number: AF05850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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
• Patient Sex: Unknown