MAUDE Adverse Event Report: QUANTUM SURGICAL SAS EPIONE

Model Number	EPIONE
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/10/2023
Type of Reportable Event	Death
Event or Problem Description
It as reported to quantum surgical on the 10 november 2023 that during an intervention, a patient treated for liver cancer by ire (irreversible electroporation) with epione device to place 6 needles, had a severe abdomen bleeding at the end of the intervention.Patient was sent to angiographic room to have arteries embolization and have blood transfusion.It was reported that patient condition was stable on the 10 november 2023.Additional information was communicated to quantum surgical on the 13th of november 2023 to inform us that patient had passed on the (b)(6) 2023.
Additional Manufacturer Narrative
The technical investigation based on epione device logs, and collected ct scans, show that there is no evidence of device malfunction, and the device has been confirmed to be within specifications for accuracy by testing performed with the same set of instruments as used during the intervention.Based on the investigation performed, the most probable root cause is that the planned needle trajectories were too close and/or crossing critical structures such as vessels.Over the 6 planned needles trajectories, 5 of them were close to anatomical structures at risk such as vessels and 2 of the 5 were crossing vessels.It was noted that no intraoperative control scan was performed after completing needle insertion as recommended per user manual (d-sy-dou-0860a_fr quick_reference_guide).The combination of the little to no margin vs critical structures of the planned trajectories, and biomechanical effects that have not been detected before end of the insertion, due to the absence of intermediate control ct scan are the main root causes of the adverse event observed during the procedure.

• Brand Name: EPIONE
• Common Device Name: EPIONE
• Manufacturer (Section D): QUANTUM SURGICAL SAS; 1000 rue du mas de verchant; zac eureka; montpellier, 34000 ; FR 34000
• Manufacturer (Section G): QUANTUM SURGICAL SAS; 1000 rue du mas de verchant; zac eureka; montpellier, 34000 ; FR 34000
• Manufacturer Contact: elise lagacherie ; 1000 rue du mas de verchant; zac eureka; montpellier, 34000 ; FR 34000
• MDR Report Key: 18290630
• Report Number: 3023140882-2023-00001
• Device Sequence Number: 19238642
• Product Code: JAK
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K223758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: EPIONE
• Device Catalogue Number: 30-0001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 70 YR
• Patient Sex: Male