MAUDE Adverse Event Report: QUANTUM SURGICAL SAS EPIONE

Model Number EPIONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/10/2023

Event Type  Death  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 330041716
• Report Number: 3023140882-2023-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K223758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EPIONE
• Device Catalogue Number: 30-0001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 70 YR
• Patient Sex: Male