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

Model Number 11823

Device Problems Material Puncture/Hole (1504); Obstruction of Flow (2423)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales representative contacted technical solutions to report a catheter revision that was performed due to a hole and occlusion in the catheter.They stated that the patient had a lack of pain relief.A dye study was performed, and it was unsuccessful.Days later, another dye study was performed and they were unable to aspirate from the catheter.During the revision surgery, a significant amount of fluid was observed at the catheter entry site.The physician cut the catheter and tried to aspirate again, which was unsuccessful.The winged anchor was removed and they tried to aspirate again, which was unsuccessful.Then, the physician used an access needle to try and push fluid through the old/removed catheter and discovered that there was a hole in the catheter at about the 24cm marking, where fluid was spraying out the side of the catheter.Doctor wanted to test whether the tip was occluded and cut the catheter at 20 cm (above the hole) and tried pushing fluid through again, which was unsuccessful.

Manufacturer Narrative

Pending completion of device analysis and review of device history record.Representative stated that they believe that the hole in the catheter was there from the beginning (or early in), and that it led to the occlusion at the catheter tip.Internal complaint number: (b)(4).

Manufacturer Narrative

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, confirming the alleged issue.Three sections of catheter were returned.The first section was 20 cm long with a distal end and occlusion was confirmed in this section.The material causing the occlusion could not be determined.The second section was 22.25 cm long with no distal end.The third section was 4.5 cm long with no distal end.Both of the last two sections were found to be patent with air and swi.No hole or leak was observed on any of the returned sections.Per the instructions for use of the device, reversible or irreversible occlusions are known possible risks of use of the device.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: 12193017
• MDR Text Key: 262528701
• Report Number: 3010079947-2021-00212
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)210816(10)26645
• 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,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 26645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention