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

Model Number	XTACK-160-H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported - the patient was bleeding which required hospital stay and was admitted to the icu.It was reported that the patient stopped taken his mediciation the day prior to the original procedure.The event happed days after the original procedure with no issues during the endoscopy.The patient is doing well.
Additional Manufacturer Narrative
Combined medwatch submitted to the fda on 23/oct/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 "vessel damage / bleeding; ischemia; other (hospitalization " 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.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: a device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number and this allegation, af04884.The subject product met all specifications and requirements in effect at the time of manufacture.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
• Common Device Name: 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: 17987558
• Report Number: 3006722112-2023-00213
• Device Sequence Number: 15268802
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20230125(11)20200125(10)AF04884
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF04884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 106 KG