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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure with a patient with unknown sedation status.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscope helix tacking system (235cm) was used during a colon hemostasis procedure performed on (b)(6) 2024.During the procedure, the x-tack "presented a defect" when removing the catheter from the working channel, pulling the wire.The procedure was not completed.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscope helix tacking system (235cm) was used during a colon hemostasis procedure performed on (b)(6) 2024.During the procedure, the x-tack "presented a defect" when removing the catheter from the working channel, pulling the wire.The procedure was not completed.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Investigation summary: an x tact was returned to boston scientific corporation where it was observed that the tack was stretched.It was not possible to replicate the event as it occurred during the procedure.The event of suture break and difficult to remove could not be confirmed.This investigation is assigned a most probable conclusion code of adverse event related to procedure.This conclusion was selected because during the product analysis the device returned with the first helix tack stretched.Most likely procedural factors such as lesion characteristics handling of the device the technique used by the physician (force applied) could have resulted in the damages encountered in the device.Block h6: impact code f1001 is being used to capture the reportable event of aborted cancelled procedure with a patient with unknown sedation status.

• 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: 18940566
• Report Number: 3005099803-2024-01139
• Device Sequence Number: 8405398
• Product Code: PKL
• UDI-Device Identifier: 20811955020777
• UDI-Public: 20811955020777
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 10/04/2026
• Device Model Number: XTACK-235-H
• Device Lot Number: AF05724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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 Age: 72 YR
• Patient Sex: Female