MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM

Model Number XTACK-160-H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

Clinical study.It was reported bleeding due to suture on the follow up visit 11 days later.Suturing during endoscopy.

Manufacturer Narrative

Combined medwatch submitted to the fda on 07/dec/2023.Clinical study: (b)(6).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 "bleeding " as follows: warnings: - the device should not be used to treat acutely bleeding ulcers, ulcers with stigmata of recent bleeding or any ulcers with a visible vessel.- do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.- only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.- contact of electrosurgical components with other components may result in injury to the patient and/or operator as well as damage to the device and/or endoscope.- 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.- suction operation through endoscope may be significantly reduced when the scope channel liner is in proper position.- 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, precautions: - the system may only be used if purchased from apollo endosurgery, inc.Or one of its authorized agents.Adverse events: possible complications that may result from using the x-tack¿ system include, but may not be limited to: - pharyngitis / sore throat.- nausea and / or vomiting.- abdominal pain and / or bloating.- hemorrhage.- hematoma.- conversion to laparoscopic or open procedure.- stricture.- infection / sepsis.- pharyngeal, gastric, colonic and/or esophageal perforation.- esophageal, gastric, colonic and/or pharyngeal laceration.- intra-abdominal (hollow or solid) visceral injury.- aspiration.- wound dehiscence.- acute inflammatory tissue reaction.- death.Additional information: the device has not been returned for analysis.Dhr review was completed for lot number, af04669.The subject product met all specifications and requirements in effect at the time of manufacture.There was one other complaint in the apollo database against this lot number af04669.Additional information: device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM
• Type of Device: ENDOSCOPIC HELIX TACKING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 18286120
• MDR Text Key: 330827871
• Report Number: 3006722112-2023-00231
• Device Sequence Number: 1
• Product Code: OCW
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF04669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 62 KG