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

Model Number 11823

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis and review of device history record.Internal complaint number: (b)(4).

Event Description

Agent contacted technical solutions via email to report a catheter that was replaced at implant due to the physician being unable to confirm csf flow.Agent reported: "during physician's final check at the last stage of the surgery, [they] aspirated from the catheter access port and did not get csf.Csf was verified earlier in the surgery during placement of the tuohy needle.Catheter was fully connected to the pump/stem.After disconnecting, physician also tried aspirating from the catheter which [they] also did not get csf.[they] trimmed the catheter a few times and aspirated again, still no csf.So we removed the remaining part of the catheter, placed a new one and it worked without any problems." agent confirmed that the surgery was delayed 30 minutes and there was no visual defects observed.

Manufacturer Narrative

Corrected information: h3, h6.Device was returned for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Additional physical investigation was performed on the device, but the alleged issue could not be confirmed.Three section of catheter were returned.The first section was 56.0 cm long and considered to be the proximal end.The second section of catheter was 25.5 cm long and was the midsection of the catheter.The last section was 23 cm long and was the distal end.The analysis of the catheter was done upon receipt and prior to the decontamination process to ensure that any occlusion that may have caused the issue was not lost.No occlusions were observed during the analysis, and all the sections were patent with air and swi.Internal complaint number: (b)(4).

• Brand Name: INTRATHECAL CATHETER
• Type of Device: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 11961917
• MDR Text Key: 260064138
• Report Number: 3010079947-2021-00166
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)221211(10)27318
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention