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

Model Number	11830
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tracking received a tracking form in the mail reporting a catheter revision due to a catheter kink.Later communication confirmed that the healthcare professional reported that a volume discrepancy of 6.4ml was found during the last refill.Prior refills were reportedly off by 4-6ml, and the patient had reported an increase of pain.During a dye study, mispositioning of the catheter was identified.The catheter tip was reportedly at t11 in the far lateral recess.Cause of the mispositioning and kink were reported to be unknown.Catheter was discarded.
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 discarded and not returned for additional evaluation and investigation.Office representative reported that the cause of the catheter kinking and catheter migration was unknown.Per the instructions for use of the device, catheter migration and catheter kinking are known possible risks of use of the device.Internal complaint number: (b)(4).

• 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: 15695694
• Report Number: 3010079947-2022-00171
• Device Sequence Number: 7359617
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)180416(10)22300
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/26/2022

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: 04/16/2018
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 22300
• 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: 08/26/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2016
• 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