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

Model Number ESS-G02-SX1

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1702 captures the reportable event of needle shaft stuck.

Event Description

It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used on an endoscopic sleeve gastroplasty performed on (b)(6) 2023.During the procedure, the anchor exchange and needle were trapped inside the channel, and it was not possible to free them.The system was trapped in the gastric fundus.It was necessary to cut the thread with endoscopic scissors in order to remove the system along with the endoscope.The device was retired from gastric fundus of patient.The patient was admitted to the hospital.The procedure was successfully completed using another device.There have been no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that an overstitch sx endoscopic suture system was used on an endoscopic sleeve gastroplasty performed on (b)(6) 2023.During the procedure, the anchor exchange and needle were trapped inside the channel, and it was not possible to free them.The system was trapped in the gastric fundus.It was necessary to cut the thread with endoscopic scissors in order to remove the system along with the endoscope.The device was retired from gastric fundus of patient.The procedure was successfully completed using another device.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Correction: the report submitted on this event on 10jan2024 (report number 3005099803-2023-07140) was submitted as a serious injury report; however, based on the information received via good faith effort on (b)(6) 2024, the patient did not require a hospitalization as a result of the product malfunction.Therefore, this event is being reportable based on the product malfunction only.Block h6: imdrf device code a1702 captures the reportable event of needle shaft stuck.

• Brand Name: OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY; 4221 freidrich ln.; ste 195; austin TX 78744
• Manufacturer (Section G): VIANT MEDICAL INC; 620 watson st sw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18486590
• MDR Text Key: 332574298
• Report Number: 3005099803-2023-07140
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20811955020715
• UDI-Public: 20811955020715
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K181141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-SX1
• Device Lot Number: 2022061513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male