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

Model Number	THX-165-028
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Imdrf code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used during an esophageal sleeve gastroplasty (esg) procedure performed on (b)(6) 2024.During the procedure, the tissue helix could not be fully removed from the tissue.The procedure was rescheduled to extract the remaining part of the device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Imdrf code f23 captures the reportable event of unexpected medical intervention.Additional information: block h6: device codes investigation summary: the device was not returned for analysis.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used during an esophageal sleeve gastroplasty (esg) procedure performed on (b)(6) 2024.During the procedure, the tissue helix could not be fully removed from the tissue.The procedure was rescheduled to extract the remaining part of the device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Imdrf code f23 captures the reportable event of unexpected medical intervention.Correction: block h6: device codes.Investigation summary: the device was not returned for analysis.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.With all the available information, boston scientific concludes that the most probable cause assigned is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a tissue helix was used during an esophageal sleeve gastroplasty (esg) procedure performed on (b)(6) 2024.During the procedure, the tissue helix could not be fully removed from the tissue.The procedure was rescheduled to extract the remaining part of the device.There were 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19977393
• Report Number: 3005099803-2024-03804
• Device Sequence Number: 12541505
• Product Code: OCW
• UDI-Device Identifier: 20811955020685
• UDI-Public: 20811955020685
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: THX-165-028
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/25/2024; 10/21/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/22/2024
• 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