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

Model Number	ESS-G02-SX1
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Open or Close (2921); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a051104 captures the reportable event of difficult to open or close.
Event or Problem Description
It was reported to boston scientific corporation that a overstitch sx endoscopic suture system was used during an esg procedure performed on (b)(6) 2024.During the procedure, the needle shaft penetrated the catheter.The procedure was completed with another of the same device.It was discovered the patient had a minor esophageal injury identified as a small cut in the mucosa with slight bleeding.No further treatment of the cut was necessary.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf code a051104 captures the reportable event of difficult to open or close.Correction: block b5: description of the problem.Block h6: device codes.
Event or Problem Description
It was reported to boston scientific corporation that a overstitch sx endoscopic suture system was used during an esg procedure performed on (b)(6) 2024.During the procedure, the needle shaft penetrated the catheter and the catheter was kinked.The procedure was completed with another of the same device.It was discovered the patient had a minor esophageal injury identified as a small cut in the mucosa with slight bleeding.No further treatment of the cut was necessary.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf code a051104 captures the reportable event of difficult to open or close device evaluation: investigation summary: with all the available information, boston scientific concludes that the most probable cause is adverse event related to procedure.The device was returned for analysis.Device media analysis: during media analysis of customer provided photos.The channel was found punctured by the anchor.Also, the channel was found kinked.Device technical analysis: during product analysis the channels were returned kinked and perforated, for this reason the as reported codes of catheter perforated and catheter kinked can be confirmed.Additionally, the handle was actuated from open to close and the needle body was moved from open to close for this reason the as reported code of needle shaft failure to close cannot be confirmed.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: a labeling review was performed using the instructions for use ifu.There is no evidence the device was improperly used per the ifu.Investigation conclusion: during analysis the handle was actuated from open to close and the needle body was moved from open to close for this reason the as reported code of needle shaft failure to close cannot be confirmed.For this reason, this actuation event is catalogued as no problem detected because the as reported code cannot be confirmed.This investigation is assigned a most probable conclusion code of adverse event related to procedure.This conclusion was selected because during the product and media analysis the device was found with the channels kinked and perforated.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician force applied could have resulted in the damages encountered in the device.
Event or Problem Description
It was reported to boston scientific corporation that a overstitch sx endoscopic suture system was used during an esg procedure performed on (b)(6) 2024.During the procedure, the needle shaft penetrated the catheter and the catheter was kinked.The procedure was completed with another of the same device.It was discovered the patient had a minor esophageal injury identified as a small cut in the mucosa with slight bleeding.No further treatment of the cut was necessary.The patient's condition at the conclusion of the procedure was reported to be fully recovered.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19804803
• Report Number: 3005099803-2024-03507
• Device Sequence Number: 7387094
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: 20811955020715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Lot Number: 2024010322
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/23/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2024
• 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
• Patient Sex: Unknown