MAUDE Adverse Event Report: FHC, INC. WAYPOINT STEREOTACTIC PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number MP-KIT-P-BI

Device Problems Image Orientation Incorrect (1305); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Muscle Weakness (1967); Dysphasia (2195); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is basedupon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date thereport was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted andhas provided as much information as is available to the company as of the submission date this report.This report does notconstitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused orcontributed to the event described in the report.In particular, this report does not constitute an admission by anyone that theproduct described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form andare fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant topart 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations impliedby these terms.This statement should be included with any information or report disclosed to the public under the freedom ofinformation act.

Event Description

During depth electrode (mer) placement, mer was not conclusive on the first pass and the microelectrode was found in imaging (in brainlab) to be roughly 2mm anterior and 3mm lateral from its expected location.Image registration was difficult due to the o-arm spin scan being flipped top to bottom.Physician was able to complete the registration and determined an offset move to target.While i was attempting to register the o-arm scan in navigator, he had removed the drive, positioner and hub to begin setup for the second pass.Equipment setup was checked.Mer was also not conclusive on the second pass.The second pass o-arm scan showed the microelectrode on the opposite side of target from the first pass.The doctors conferred and concluded the initial center track should have placed them at target and decided to try that again, with an electrode also in the posterior track to add additional mer data, hoping to not need a fourth pass.Mer on both center and posterior tracks of the third pass was good enough for the doctors to place a lead in the posterior track.An o-arm spin was not done, as post op ct had been scheduled and they didn't want to expose the patient to excessive radiation.No equipment was noted as damaged or not working properly.During this surgery there was no known patient injury or delay other than multiple track mer that might be expected during dbs procedures.On (b)(6) 2022 physician notified of several symptoms observed in patient - "several symptoms likely from passing into her caudate from the off target electrodes" and the patient being "weak, has word finding difficulties, confusion, and imbalance." on (b)(6) 2022 field rep followed up with physician and noted: "recovering.I think she'll be fine.Thanks for checking.".

Manufacturer Narrative

In review of this rn, eng determined this was a user error not a result of fhc product.The fhc product was discarded, however, in review of the dhr and with additional information from the fhc field tech in attendance and patient scans they were able to come to this determination.During the course of this case, the dr had disassembled their equipment setup and assembled again and were able to complete the case successfully.The customer set up included alpha omega drive, electrodes and cannulas.

• Brand Name: WAYPOINT STEREOTACTIC PLATFORM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): FHC, INC.; 1201 main street; 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: 15005678
• MDR Text Key: 295861841
• Report Number: 3002250546-2022-00002
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00873263005903
• UDI-Public: 00873263005903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MP-KIT-P-BI
• Device Catalogue Number: MP-KIT-P-BI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other