MAUDE Adverse Event Report: APOLLO ENDOSURGERY TISSUE HELIX; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	THX-165-028
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4 detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1 detailed initial reporter information was not provided to bsc.We completed a good faith effort to obtain the information.Because the initial reporter information is unknown at this time, we are unable to provide the complete initial reporter specific information.Block h6 device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf f19 is being used to capture the reportable event of surgical intervention.Imdrf f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Imdrf f1001 is being used to capture the reportable event of cancelled/rescheduled procedure.
Event or Problem Description
Procedure summary: it was reported to boston scientific corporation that a tissue helix was used during an endoscopic sleeve gastroplasty procedure performed on (b)(6) 2025.Event summary: during the procedure, the helix got sucked and disappeared in the mucosa.Two days post- procedure the patient presented abdominal pain.The patient was scheduled for a followed up and it was discovered that there was a small perforation, the perforation was sutured.Patient status: there were patient complications as a result of this event, small perforation.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TISSUE HELIX
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22418756
• Report Number: 3005099803-2025-03201
• Device Sequence Number: 8817981
• Product Code: OCW
• UDI-Device Identifier: 20811955020685
• UDI-Public: (01)20811955020685
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K181141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/07/2025
• 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
• Patient Sex: Unknown