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

Model Number 11823

Device Problems Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/12/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 305597333
• Report Number: 3010079947-2022-00221
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)150601(10)19413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female