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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: additional information was received on (b)(6), 2024.Block a1: patient identification block b5: description of the problem correction: block b1: adverse event / product problem block b2: outcomes attrib to adv event block f10: patient / impact codes block g2: report source - legal block h1: type of reportable event block h6: patient / impact codes imdrf impact code f1001 captures the reportable event of absence of treatment imdrf impact code f2202 captures the reportable event of endoscopic procedure imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization imdrf impact code f19 captures the reportable event of surgical intervention device analysis a handle of the tissue helix was returned.Engineering examined the device prior to decontamination and did not find any discrepancies.Engineering inspected the tissue helix handle, and it locks and unlocks as intended.The wire inside the helix handle is assembled correctly.For this reason, the as reported code of "difficult to remove" cannot be confirmed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.H3 other text : investigation previously provided on supplemental mdr 3006722112-2023-00077.
Event or Problem Description
This event was previously reported by apollo endosurgery.The initial (b)(6) 2023) and supplemental (b)(6) 2023 medwatch reports were submitted under number 3006722112-2023-00077.Apollo endosurgery was acquired by boston scientific corporation (b)(6) 2023.However, boston scientific corporation began processing complaints for apollo endosurgery devices on (b)(6) 2023.Additional information regarding the event was received on (b)(6), 2024.It was reported to apollo endosurgery / boston scientific corp.That the tissue helix was unable to be removed from the patient resulting in an aborted procedure.The event required additional endoscopic and laparoscopic procedures, hospitalization, and prolonged episode of care.Therefore, this has been deemed a serious injury reportable event.Boston scientific corporation reviewed this information on (b)(6), 2024 and determined that a correction report needed to be submitted.

• 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: 19137884
• Report Number: 3005099803-2024-01560
• Device Sequence Number: 21191618
• Product Code: OCW
• UDI-Device Identifier: 20811955020685
• UDI-Public: 20811955020685
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 04/18/2024

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 Expiration Date: 11/09/2025
• Device Model Number: THX-165-028
• Device Lot Number: AF05306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3006722112-2023-00077
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male