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

Model Number	THX-165-028
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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 h6: device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf code f2301 is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic submucosal dissection (esd) closure procedure in sigmoid colon on (b)(6) 2025.During the procedure, the tissue helix became stuck in the patient's tissue.The physician used forceps to remove the helix.The procedure was completed with the same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf code f2301 is being used to capture the reportable event of additional device required.Correction: block d4, h4 upn received as additional information on october 21, 2025, and was updated in this report.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic submucosal dissection (esd) closure procedure in sigmoid colon on (b)(6) 2025.During the procedure, the tissue helix became stuck in the patient's tissue.The physician used forceps to remove the helix.The procedure was completed with the same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 device code a150207 is being used to capture the reportable event of helix failure to remove.Imdrf code f2301 is being used to capture the reportable event of additional device required.Correction block d4, h4 upn received as additional information on october 21, 2025.Block h11 the returned overstitch device was analyzed.During the visual inspection, no visible damage was observed on the handle.However, the protective sheath was found to be broken and detached.The device opens and closes with manual assistance due to damage to the protective sheath; however, rotation could not be performed.For this reason, there is enough evidence to confirm the reported events of handle break and helix failure to remove.The inability of the device to rotate significantly contributed to the difficulty in removing the device from the patient's tissue, as rotation is a critical function for disengaging the tissue helix during the procedure.Without rotation, the helix remains embedded, requiring additional interventions to free the device, which increases procedural complexity and risk.Most likely, procedural factors such as handling of the device and the technique used by the physician (force applied), could have resulted in the damages encountered in the device.For this reason, this event is catalogued as adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.For the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.For this reason, will be classified as cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch ess was used during an endoscopic submucosal dissection (esd) closure procedure in sigmoid colon on (b)(6) 2025.During the procedure, the tissue helix became stuck in the patient's tissue.The physician used forceps to remove the helix.The procedure was completed with the same device.There was no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23360984
• Report Number: 3005099803-2025-05399
• Device Sequence Number: 12965609
• Product Code: OCW
• UDI-Device Identifier: 20811955020685
• UDI-Public: (01)20811955020685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 12/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown