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
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack was used during an emr procedure performed on (b/)(6) 2024.During preparation of the device physician cut and removed the scope liner funnel.While advancing the 4th x-tack through the scope, a piece of coiled plastic from the scope appeared when the tack came out of the distal end of the scope.All coiled plastic pieces were removed with biopsy forceps and rat tooth forceps.The 4th tack was removed, and the 3 initial x-tacks were cinched.The procedure was completed using clips.Altering of the device, cutting the scope liner funnel, allowed damage to the working channel of the scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code f23 captures the reportable event of unexpected medical intervention.Imdrf code a1702 captures the reportable event of device interaction with another device.Evaluation results: the device was not returned for analysis.All compiled information on this investigation determines that the most probable cause is: failure to follow instructions.A labeling review was performed using the instructions for use (ifu).The found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.It was reported that the protective sheath was removed before it was pass down the scope, however the ifu states that insert device with scope liner into the working channel of the scope.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Evaluation conclusion: based on the information provided, the protective sheath was removed before it was pass down the scope.Therefore, the event most probable cause is failure to follow instructions because the problems traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack was used during an emr procedure performed on (b)(6) 2024.During preparation of the device physician cut and removed the scope liner funnel.While advancing the 4th x-tack through the scope, a piece of coiled plastic from the scope appeared when the tack came out of the distal end of the scope.All coiled plastic pieces were removed with biopsy forceps and rat tooth forceps.The 4th tack was removed, and the 3 initial x-tacks were cinched.The procedure was completed using clips.Altering of the device, cutting the scope liner funnel, caused the damage to the working channel of the scope.There were no patient complications reported as a result of this event.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (235CM)
• Common Device Name: 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: 19702368
• Report Number: 3005099803-2024-03173
• Device Sequence Number: 18072533
• Product Code: PKL
• UDI-Device Identifier: 20811955020777
• UDI-Public: 20811955020777
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Expiration Date: 09/26/2026
• Device Model Number: XTACK-235-H
• Device Lot Number: AF05710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 10/16/2024
• Date Device Manufactured: 09/26/2023
• 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: Other
• Patient Sex: Male