MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endosleeve procedure performed on (b)(6) 2024.During the procedure, the needle got stuck into the gastric wall, it was necessary to cut the cable between the handle and the needle with a surgical cutter to detach the needle from the gastric wall.The procedure was cancelled.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device code: a150208 is being used to capture the reportable event of needle shaft stuck.Impact code f1001 is being used to capture the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Impact code f23: is being used to capture the reportable event of unexpected medical intervention.Block h11: the returned overstitch sx endoscopic suture system was analyzed.A functional and visual test was performed.The device was returned without the anchor exchange and with the catheter unraveled and detached, also the needle was inspected, and no damages were found.Additionally, the needle driver handle was closed, an inspection pin was slide out of the anchor exchange channel and toward the needle body.The needle body tip fit into the alignment pin hole, without any problems.Based on all gathered information, the probable cause selected is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on event.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Additional Manufacturer Narrative
Block h6: device code a150208 is being used to capture the reportable event of needle shaft stuck.Impact code f1001 is being used to capture the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Impact code f23: is being used to capture the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used during an endosleeve procedure performed on (b)(6) 2024.During the procedure, the needle got stuck into the gastric wall, it was necessary to cut the cable between the handle and the needle with a surgical cutter to detach the needle from the gastric wall.The procedure was cancelled.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM
• 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): VIANT MEDICAL INC; 5079 33rd street; grand rapids MI 49512
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20869514
• Report Number: 3005099803-2024-06037
• Device Sequence Number: 12969455
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: 20811955020715
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210266
• 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
• Report Date (Section B): 03/05/2025

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: ESS-G02-SX1
• Device Lot Number: 2024020292
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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