MAUDE Adverse Event Report: FHC, INC. MICROTARGETING¿ INSERTION TUBE SET

Model Number	66-IT-05P-00432
Medical Device Problem Codes	Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Fhc technician received a call on the evening of 9/24/2024 from dr.(b)(6) from (b)(6) during a dbs surgery.Dr.(b)(6) was unable to perform mer recordings with his 66-it-05p lot#: 244517 because the reducing cannula was much too long and extended beyond the lead insertion tube, preventing mer (the microelectrode never came out of the reducing cannula).The case was delayed slightly while surgeon tried to figure out why he couldn't get the mer system to record.The surgeon opened a different lot of 66-it-05p and was able to complete the case successfully.There was no patient injury.
Additional Manufacturer Narrative
Our initial investigation has found that the reducing cannula, included in the 66-it-05p, lot id: 244517 was built using the wrong drawing and resulted in the cannula being 20 mm longer than specified.This resulted in the reducing cannula extending down 20 mm below the end of the insertion tube, the target location.Our hazard analysis has determined that there is a risk of hemorrhage and unintended coring of brain tissue resulting from advancement of a cannula with no stylet in place.There have been no reports of patient death or injury related to this problem.We have determined this to be a recall.

• Brand Name: MICROTARGETING¿ INSERTION TUBE SET
• Common Device Name: MICROTARGETING¿ INSERTION TUBE
• Manufacturer (Section D): FHC, INC.; 1201 main st.; bowdoin ME 04287
• Manufacturer (Section G): FHC, INC.; 1201 main street; bowdoin ME 04287
• Manufacturer Contact: kelly moeykens ; 1201 main street; bowdoin, ME 04287 ; 2076665651
• MDR Report Key: 20362990
• Report Number: 3002250546-2024-00003
• Device Sequence Number: 8004386
• Product Code: HAW
• UDI-Device Identifier: 00873263004326
• UDI-Public: 00873263004326
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K011775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66-IT-05P-00432
• Device Catalogue Number: 66-IT-05P
• Device Lot Number: 244517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002250546-10/1/24-001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose