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

Model Number	11830
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that reported that a patient's pump and catheter were replaced.Initially, the patient called into the physician's office requesting an increase in dose due to increasing pain over the previous two months.The patient denied any falls or injuries.The patient was later seen for a scheduled refill and an underinfusion volume discrepancy was observed.The expected volume was 4.519ml and the actual aspirated volume was 19ml.The patient believed that they could have had withdrawal symptoms as well.The patient later had an explant procedure performed.During the surgery, it was observed that the catheter was kinked and twisted in the pump pocket.It was reported that the patient's pump was replaced due to the pump's age and since the catheter was already being replaced.The physician believes that the issues reported for this patient are related to this kinked catheter, but the cause of the kinking is unknown.
Additional Manufacturer Narrative
Pending return of device for analysis.A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter revision kit, verification of all final testing performed by/on the us catheter revision kit, and packaging for subject us catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter revision kit function.Internal complaint number: (b)(4).
Additional Manufacturer Narrative
Device was returned for additional evaluation and investigation.Two sections of catheter were returned.One section was a 5.08 cm section of flowonix catheter connected with 1.27 cm section of flowonix catheter with a barb, with no distal end.The second section was a 41.91cm of non-flowonix catheter with no distal end.Both sections were patent with air and swi.The patient's pump was also returned with the catheter.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.No issues found with the pump.Although it was reported that the catheter was observed to be kinked and twisted in the pump pocket during the surgery, this was unable to be confirmed during the investigation.Per the instructions for use of the device, catheter kinking is a known possible risk of use of the device.The cause of the alleged issue was not able to be confirmed.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: 13618782
• Report Number: 3010079947-2022-00032
• Device Sequence Number: 5644135
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)161018(10)19798
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 10/18/2016
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 19798
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2014
• 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