MAUDE Adverse Event Report: ENDO TOOLS THERAPEUTICS S.A ENDOMINA SYSTEM; ENDOMINA PLATFORM PART OF ENDOMINA SYSTEM

Model Number	IA-EM8616610505-0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Gastrointestinal Hemorrhage (4476)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an intervention using the endomina(r) system on (b)(6), 2023, an arterial bleeding occurred.Intra-procedural hemostasis was successfully performed, and the procedure was appropriately aborted.The device was thrown away by the medical staff in charge of the procedure and could not be retrieved.The patient was discharged the next day without problem, as initially planned.The vendor's representative only had confirmation of the patient state of health and day of discharge through a phone call two days later.Since the incident contact was established with the site and the physician at least once a week.No other concerns were raised.On (b)(6), 2023, company received a medwatch from mayo clinic reference (b)(4).Context: the endomina case was the first one in this hospital, therefore, a physician expert in the technique and a vendor field specialist came for proctoring.It was identified that the bleeding was related to the use of the devices and had been caused by a user error.Root cause analysis: the device responsible for the bleeding was the endomina(r) platform/ after unbending the arm (bendable coil) of the platform, some tissue was caught into the system without being directly detected.Movements of the platform induced by users to move forward with the procedure teared the gastric wall and led to the bleeding.This root cause analysis was determined by the vendor's representative (field clinical specialists) and discussed with the clinical affairs director (lead field clinical specialist) who have extensive technical knowledge of the products.Also, the tissue tear was confirmed orally by the physician proctoring the endoscopist.Working without visual control or against resistance are described in the warnings section of the ifu.The root cause analysis involving tapes for this event does not seem relevant.It could not either have been a contributory factor.By design, even if a malfunction of the sheath occurs that would let the tip of the needle pass, it could not lead to such a bleeding.Indeed, the tip of the needle of tapes errouneously passing through the coil of the endomina(r) platform could only lead to superficial scratches.In conclusion, endo tools therapeutics us corp.Confirms the pre-root cause analysis written on (b)(6), 2023 in the internal documentation.The device contributory of the incident is the endomina(r) platform.The event occurred due to unbending without visual control and moving the device against resistance which are contraindications of the ifu.Finally, the patient was supposed to stay overnight, by plan, before the incident, and therefore no prolonged hospitalization was accounted for.

• Brand Name: ENDOMINA SYSTEM
• Common Device Name: ENDOMINA PLATFORM PART OF ENDOMINA SYSTEM
• Manufacturer (Section D): ENDO TOOLS THERAPEUTICS S.A; rue auguste piccard, 48; gosselies, 6041 ; BE 6041
• Manufacturer (Section G): MEDI-LINE; rue des gardes frontières 5; angleur, 4031 ; BE 4031
• Manufacturer Contact: marine rouyer ; rue auguste piccard, 48; gosselies, 6041 ; BE 6041
• MDR Report Key: 17340670
• Report Number: 3021721805-2023-07181
• Device Sequence Number: 6903012
• Product Code: OCW
• UDI-Device Identifier: 05425029282018
• UDI-Public: 05425029282018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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?: No
• Device Expiration Date: 11/04/2024
• Device Model Number: IA-EM8616610505-0
• Device Lot Number: 41398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White