MAUDE Adverse Event Report: FHC, INC MICROTARGETING INSERTION TUBE; INTRACRANIAL CANNULA

Model Number 66-IT-1028

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Device has not been returned yet.

Event Description

Fhc's product 66-it-1028 was used in dbs procedure.During the procedure, the surgical team noticed a separated piece of the material in the brain.The electrode was just above, pushing the piece.At the same time, the patient started dyspnea and potentially a peduncle syndrome.The procedure was stopped to stabilize the patient and was sent to ct scan.Ct scan confirmed the presence of a piece of 66-it-1028.The material was removed from brain with no complications during the removal.The dbs procedure could not be completed.The patient is being monitored in intensive care.The following day patient exhibited difficulty on opening the eye and no other neurological deficit.Fhc is still waiting for more news about recovery of the patient and also for the return of 66-it-1028 from facility to investigate further on this device.

• Brand Name: MICROTARGETING INSERTION TUBE
• Type of Device: INTRACRANIAL CANNULA
• Manufacturer (Section D): FHC, INC; 1201 main street; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: samhitha mohan ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 6666541
• MDR Text Key: 78377698
• Report Number: 3002250546-2017-00004
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K011992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/23/2017

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 Operator: Physician
• Device Expiration Date: 09/22/2019
• Device Model Number: 66-IT-1028
• Device Lot Number: 223942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization