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

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

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 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.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM)
• Type of Device: 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
• MDR Text Key: 338129800
• Report Number: 3005099803-2024-01139
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 20811955020777
• UDI-Public: 20811955020777
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K201808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTACK-235-H
• Device Lot Number: AF05724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female