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

Model Number 11823

Device Problem Obstruction of Flow (2423)

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

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint # (b)(4).Internal complaint # (b)(4) (mfr 3010079947-2020-00236) captures the prometra ii 20 ml pump, serial number: (b)(4), potentially associated with this event.Device analysis will be performed following return of the devices as it is not clear whether the event is due to the catheter or the pump.

Event Description

Sales representative reported a prometra ii 20 ml pump that was explanted due to a lack of pain relief and inability to aspirate the catheter.After being unable to aspirate from the cap, sales representative reported that the physician decided to replace the entire system.Per the information received, there was only one volume discrepancy reported, in which the expected volume was 14.2 mls and the returned was 15 mls.The primary medication and the secondary medication was reported to be bupivacaine.This report (mfr 3010079947-2020-00235) captures the catheter and mfr 3010079947-2020-00236 captures the prometra ii 20 ml pump.

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.Two sections of catheter were returned with the pump.One section 30.5 cm long with the distal end.The section of catheter was patent with air and swi.The second section was 78.75 cm long with no distal end.This section was not patent with air or swi.This occlusion is the likely cause for the issue observed in this complaint.The root cause for the occluded catheter could not be determined, but is likely due to hardening of csf or drug.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: 10038814
• MDR Text Key: 192655304
• Report Number: 3010079947-2020-00235
• 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: 05/02/2020

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: 01/12/2020
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 24196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 05/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention