MAUDE Adverse Event Report: MONTERIS MEDICAL MONTERIS NEUROBLATE SYSTEM; INTERSTITIAL THERMAL LASER

Model Number DTP-101-01

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2015

Event Type  Injury  

Event Description

This was a (b)(6) patient with a history of seizures and a astrocytoma.The patient was having laser interstitial thermal therapy procedure on her astrocytoma.She was taken to the siemens realtime mir for the procedure which was performed without complication.The complication occurred when the laser probe was being removed.During the completion of the ablation procedure, the laser tip was withdrawn from the cranium bolt and it was noticed that the laser crystal, or stylus, was not attached to the wand.It was necessary for the patient to be taken to the operating room and the burr hole enlarged to remove the stylus.The patient went home the following day and post op follow up was very positive.There were no complications with the second operating room visit to retrieve the stylus.

• Brand Name: MONTERIS NEUROBLATE SYSTEM
• Type of Device: INTERSTITIAL THERMAL LASER
• Manufacturer (Section D): MONTERIS MEDICAL; plymouth MN
• MDR Report Key: 4649049
• MDR Text Key: 19720038
• Report Number: 4649049
• Device Sequence Number: 1
• Product Code: LLZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: DTP-101-01
• Device Lot Number: 20414-1-C4663-16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2015
• Distributor Facility Aware Date: 03/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR