MAUDE Adverse Event Report: DIXI MEDICAL SAS ACS-KIP-600 COAGULATION ELECTRODE

Model Number COAGULATION ELECTRODE

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 03/27/2023

Event Type  Injury  

Event Description

This event happend in france, according to fda requirements a medwatch is opened to inform the us authorities.This case has been referenced in a communication with (b)(6), phd on (b)(6) 2023 as per mdr 3014527920-2023-00001.Summary of the event: on the post-electrode removal scan, the surgeons noticed that there was still a radio-opaque element in the cranial cavity in the path of one of the electrodes.The patient had to be re-operated and a foreign body was removed.After analysis, it turned out to be the sheath of the coagulation probe used to coagulate the dura mater, which had become detached during the implantation procedure.A materiovigilance declaration was made to ansm.

Manufacturer Narrative

The submission of this medwatch relating to an incident in france was submitted after the 30 days required by us law.A capa has been initiated by dixi medical to remedy this deviation, including training of internal teams and review of procedures to prevent this type of situation in the future.

• Brand Name: ACS-KIP-600 COAGULATION ELECTRODE
• Type of Device: COAGULATION ELECTRODE
• Manufacturer (Section D): DIXI MEDICAL SAS; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer (Section G): DIXI MEDICAL SAS; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• Manufacturer Contact: cedric boesch ; 2a rte de pouligney; marchaux-chaudefontaine, doubs 25640 ; FR 25640
• MDR Report Key: 17226040
• MDR Text Key: 318101611
• Report Number: 3014527-2023-00002
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

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 Model Number: COAGULATION ELECTRODE
• Device Catalogue Number: KIP-ACS-600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention