MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. INTRATHECAL CATHETER

Model Number	11830
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fatigue (1849); Discomfort (2330)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter revision kit, verification of all final testing performed by/on the us catheter revision kit, verification of sterilization, and packaging for subject us catheter revision kit was performed.The review did not identify any non-conformance's, issues or capas associated with us catheter revision kit function.Device was not returned.Per the instructions for use of the device, catheter migration is a known possible risk of use of the device.Note, patient's pump was explanted due to the patient's desire to not use the pump anymore.Internal complaint number: complaint-(b)(4).
Event or Problem Description
Reporter initially contacted technical solutions to inquire about how to turn a patient's pump off.Reporter stated that the patient has saline in their pump at a minimal flow rate and is currently waiting to have their pump explanted.Reporter stated that they visited the patient for a refill approximately a year ago and found that the pump was empty when it was not expected to be.At that time, the patient informed the reporter that they had flu-like symptoms for the previous 10 days that resulted in them going to the er.The hospital could not test for covid at the time, but informed the patient that they most likely had covid.The reporter went on to explain that, after this incident, a dye study was performed which showed a leak.The reporter did not know any more information.Later communication with the reporter confirmed that the dye study did not show a leak, but instead showed that the catheter had migrated out of the intrathecal space.The physician decided to perform a pump explant rather than a catheter revision because the patient stated that they no longer wanted to use the pump.It is believed that the catheter remains implanted.

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 16399507
• Report Number: 3010079947-2023-00020
• Device Sequence Number: 20219704
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)200827(10)24655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2020
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 24655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male