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

Model Number	11823
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/12/2022
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 was discarded and was not returned for additional evaluation and investigation.Clinical specialist (cs) stated that the physician suspected that the catheter coiling was the reason for the decrease in therapy.Per the instructions for use of the device, catheter coiling is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) provided a patient tracking implant form through email reporting a total system replacement.Cs stated that the replacement was due to a lack of pain therapy as well as the pump being almost 10 years old.A myelogram was performed and the catheter was unable to be aspirated.During the surgery, it was observed that the majority of the catheter's length was coiled by the spinal incision.Cs stated that the physician suspects that this coiling is the reason for the decrease in therapy.Cs stated that they also believed that the patient had a full volume discrepancy at their last refill.Cs reported that the physician abandoned the case after multiple attempts to run the new catheter and plans to refer the patient to a neurosurgeon.The new pump was placed in the existing pocket.The old devices were discarded.

• 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: 15995463
• Report Number: 3010079947-2022-00221
• Device Sequence Number: 6089326
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)150601(10)19413
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted 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): 12/12/2022

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: 06/01/2015
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 19413
• 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: 12/12/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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