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

Model Number	11823
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Seroma (2069)
Date of Event	10/27/2021
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 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.Device was discarded and not returned for additional evaluation and investigation.It was reported that the seroma and csf leak was likely due to two areas of the catheter rubbing together over time and creating a hole.Per the instructions for use of the device, pump pocket seromas and tears and holes in the catheter are known possible risks of use of the device.(b)(4).
Event or Problem Description
Clinical specialist (cs) reported a catheter revision.It was reported that the patient had swelling at their pump pocket.It was believed that the swelling was due to a csf leak.When the catheter was revised, it was noted that it looked like two areas of the catheter had been rubbing against each other, creating a hole.The revised segment of catheter was 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: 12820011
• Report Number: 3010079947-2021-00317
• Device Sequence Number: 4957549
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)221120(10)27219
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/27/2021

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: 11/20/2022
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27219
• 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: 10/27/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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: Male