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

Model Number 11823

Device Problems Leak/Splash (1354); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Pending information regarding alleged causality a review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function.Device was not returned for additional evaluation and investigation.Per the instructions for use of the device, catheter migration and catheter leakage are both known possible risks of use of the device.Internal complaint number: (b)(4).

Event Description

Agent reported that a catheter revision occurred due to catheter leak and migration.Originally, the patient alleged unrelieved pain.A dye study was performed that showed the catheter tip had migrated a few vertebral levels, a catheter leak, and that drug was not reaching the interthecal space.During the revision, it was discovered that the catheter had broken at the anchor.Agent reported that a new catheter was implanted, csf was observed flowing from the new catheter and that injected dye was able to travel to the interthecal space.The revised catheter was not returned as the tip was not found and the segment was left in the spine.

Manufacturer Narrative

Representative confirmed that the cause of the migration/leak was believed to be related to the catheter coming off of the pump.Internal complaint number: (b)(4).

Event Description

Additional communication from representative confirmed that the patient initially had a revision because the catheter had come off the pump stem, and a portion of catheter was added during the revision.It was confirmed that the cause of the migration/leak was believed to be related to the catheter coming off of the pump.

• Brand Name: INTRATHECAL CATHETER
• Type of Device: 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: 12020481
• MDR Text Key: 261715099
• Report Number: 3010079947-2021-00170
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)221002(10)27050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention