MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. X-TACK ENDOSCOPIC HELIX TACKING SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	XTACK-235-H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to close defect from emr (endoscopic mucosal resection) with apollo x-tack suture system.Device would not deploy properly.Provider was able to implant one helix, but unable to remove the catheter without pulling helix out of tissue.Called vendor rep for assistance, and watched videos of device.Still unable to get device to work properly.Finished procedure without closing defect.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 12851324
• Report Number: 12851324
• Device Sequence Number: 17145215
• Product Code: OCW
• UDI-Device Identifier: 10811955020770
• UDI-Public: (01)10811955020770(17)211205(10)AF04218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 11/18/2021

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 Catalogue Number: XTACK-235-H
• Device Lot Number: AF04218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 11/18/2021