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

Model Number	11827
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/12/2019
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 catheter revision kit, verification of all final testing performed by/on the catheter revision kit, verification of sterilization, and packaging for subject catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter revision kit function.Device was not returned for additional evaluation and investigation.Per the instructions for use of the intrathecal catheter, catheter kinking is a known possible risk of use of the device.Follow-up with the physician was not possible as the patient could not remember the physician's name.No further information was able to be obtained.Internal complaint number: (b)(4).
Event or Problem Description
A patient contacted technical solutions to report that they had their pump explanted about two years ago due to a lack of pain relief.Per the patient, the surgery was initially performed to replace the pump, but during the surgery, it was discovered that the catheter was kinked.Physician replaced both the pump and the catheter, but allegedly concluded there was no issue with the pump.

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 11986430
• Report Number: 3010079947-2021-00160
• Device Sequence Number: 4305790
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)170205(10)19960
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 02/05/2017
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Device Lot Number: 19960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention