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

Model Number	11823
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Swelling/ Edema (4577)
Date of Event	06/21/2022
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 kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device remains implanted and was not returned for additional evaluation and investigation.As the device was not returned for additional investigation, a definitive root cause could not be determined for the alleged issue.Agent confirmed that the alleged issue has resolved.Per the instructions for use of the device, csf leak is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Agent reported that the patient had an exploratory surgery performed on their pump pocket following swelling at the pump site after implant.The agent stated that the exact date of the procedure was unknown, but the physician was able to diagnose a csf leak.Per agent, this was due to the placement of the catheter and develop pretty quickly after implant.A blood patch was not performed, and the issue has since resolved.This patient is the same patient referenced in mdr 3010079947-2022-00220.

• 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: 16042456
• Report Number: 3010079947-2022-00219
• Device Sequence Number: 4924950
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)231009(10)28352
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/01/2022

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: 10/09/2023
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 28352
• 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: 12/01/2022
• Initial Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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
• Patient Sex: Female