MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM

Model Number XTACK-160-H

Device Problems Difficult to Fold, Unfold or Collapse (1254); Unintended Collision (1429)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on 05/jun/2023.A review of the device labeling notes the following: the current x-tack¿ endoscopic helix tacking system instructions for use (ifu) addressed the known and potential events of difficulty advancing catheter as follows: warnings: verify compatibility of endoscope size, endoscopic instruments and accessories and ensure performance is not compromised.Ensure endoscope is clean, dry, and free of lubricants prior to device installation.Ensure all endoscopic scopes, including scope channels, are in good working condition prior to use.Do not push through or pull back on a retroflexed scope with installed helix tack.Applying excessive force to the distal end of the x-tack¿ device could compress or damage the helix tack when installed.Do not retract device into scope whilst a helix tack is installed.Reuse or reprocessing of the x-tack¿ system could result in device malfunction, patient infection or the transmission of disease do not push through or pull back on a retroflexed scope with installed helix tack.Applying excessive force to the distal end of the x-tack¿ device could compress or damage the helix tack when installed.Do not retract device into scope whilst a helix tack is installed.Reuse or reprocessing of the x-tack¿ system could result in device malfunction, patient infection or the transmission of disease fully seat scope liner funnel in scope cap.Remove the helix tack backer card from the device catheter.Note: ensure the suture is not captured between the backer card and bracket.If required, create suture slack by pulling proximal end of the suture and allow to work through helix tacks.To reduce suture slack, pull suture tail in opposing direction.Note: ensure suture slack between scope channel funnel and backer card is not wrapped around device catheter prior to attaching to scope bracket.Note: should the suture become wrapped around catheter after backer card attachment, it will resolve itself once catheter is removed for helix tack re-loading.Additional information: combined report.The investigator determined that a device history record (dhr) review is not possible for this complaint, as the device serial and lot number are currently unknown.

Event Description

Suture became entangled within the endoscope.The procedure was successfully completed with a competitive device.The patient is doing well.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 20/jul/2023.Additional information: a device history record (dhr) review was requested as the device is a reported event.This lot was part of a rework.This rework consisted of replacing the channel liner-funnel and the suture.According to the description of the complaint, the suture becomes entangled within the scope liner; it is considered that this could be due to incorrect handling of the device and is not related to rework.There were no other complaints in the apollo database against this lot number (af05324).Device evaluation summary: the device was returned to the apollo device analysis laboratory on 13/june/2023.An xtack was returned with the tack and suture stuck in the funnel scope.Engineering visually inspected the device and found the suture is tangled in the scope liner and the suture is wrapped around the catheter as well.The driver and ball are present on the device.The complaint has been verified as the suture is tangled in the funnel scope.Lab analysis was able to replicate the reported event of "difficulty advancing catheter", as the suture is tangled in the funnel scope.The user effect of "difficulty advancing catheter" is known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 17059738
• MDR Text Key: 317650790
• Report Number: 3006722112-2023-00113
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20251116(11)20221116(10)AF05324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF05324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG