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

Model Number	11823
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/10/2022
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 pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was not returned for additional evaluation and investigation.As additional investigation was not performed on the device, a definitive root cause for the alleged issue could not be determined.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Reporter contacted technical solutions to report that a patient's pump was explanted due to the device malfunctioning.Additional information was provided, which confirmed that a dye study had been performed in which the physician was unable to aspirate from the pump.During the explant procedure, the expected volume of drug in the pump was 16.4ml and 25ml was able to be withdrawn from the pump.The patient's pump and catheter were replaced with medtronic devices.
Additional Manufacturer Narrative
Devices were returned for additional evaluation and investigation.Visual inspection of the pump did not find any exterior anomalies.Functional analysis of the pump confirmed the pump successfully primed and flowed within design specifications.The current battery level was read and found to be within specification.Engineering did a reading of the prior 30 days of battery measurements and found five instances of the battery being "low" and two instances of the battery being "marginal".As the pump was explanted on (b)(6) 2022 and not received for analysis until (b)(6) 2023, flowonix is unable to account for the conditions during this time frame.Pump storage and/or conditions during transit may be a factor in the results of the battery readings that were "low" and "marginal".Two sections of catheter were received with the pump.A 101 cm section of catheter was returned with a distal end and was found to be occluded.It was not patent with air or sterile water injection (swi), confirming the complaint of underinfusion and issue with aspirating during dye study.The second section of catheter was 7.6 cm long and was found to be patent with air and swi.The section of occluded catheter was likely the reason for the issue observed in the complaint.Please note that the intended selection for the investigation finding code was: blockage identified.The code was not able to be selected at this time.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: 16459848
• Report Number: 3010079947-2023-00018
• Device Sequence Number: 19446531
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)211203(10)26087
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 12/03/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 26087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2019
• 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 Age: 68 YR
• Patient Sex: Female