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

Model Number 11823

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pending further follow-up information and device return for analysis.

Event Description

Sales representative initially reported a prometra pump system with alleged volume discrepancies.Patient reported a lack of pain relief.Representative reported that the pump "working fine" at the initial refill and the one after, but the previous 2 refills had volume discrepancies: date unknown: expected volume: 9 mls returned volume: 40 mls.On (b)(6) 2020: expected volume: 25.632 mls returned volume: 35 mls the patient is reported to have a flowonix catheter that does not contain any segments from other companies.Primary medication was bupivacaine and secondary medication was clonidine.Per follow-up, explant occurred on (b)(6) 2020 in which "no pump replacement was done." instead, a replacement catheter segment was spliced to the pump segment.Upon explant, representative reported, "we did back table prime and did not see any drug coming out of pump / catheter.".

Manufacturer Narrative

Sales representative confirmed that the explanted catheter was discarded and would not be returning for additional evaluation and investigation.A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.As the device was not returned for additional investigation, no definitive root cause was able to be determined for the alleged issue.Internal complaint number: (b)(4).

• Brand Name: PROMETRA INTRATHECAL CATHETER
• Type of Device: IMPLANTABLE INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive, nj
• MDR Report Key: 10038716
• MDR Text Key: 191241965
• Report Number: 3010079947-2020-00234
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention