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

Model Number 11823

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Pending confirmation of device revision and potential device return.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 remains implanted at this time and was not returned.Physician did not speculate as to why or how the catheter could have migrated.Per the instructions for use of the device, catheter migration is a known possible risk of use of the device.Internal complaint number: (b)(4).

Event Description

Representative reported that a catheter revision was planned due to a dye study confirming that the catheter had migrated.It was confirmed that the catheter dye study was unsuccessful.No dye was injected, but it was confirmed that the tip of the catheter was at l4, when it was previously placed in the thoracic space.The patient had complained of increased pain.The physician did not speculate as to why or how the catheter could have migrated.

Manufacturer Narrative

Device was replaced and was not returned.Internal complaint number: (b)(4).

Event Description

Caheter was replaced and was not returned.

• 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: 13172248
• MDR Text Key: 284904398
• Report Number: 3010079947-2022-00002
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)230212(10)27569
• 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: 12/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Patient Sex: Male