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

Model Number 11823

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the volume of undelivered drug remaining in the drug reservoir was greater than the expected volume based upon the programmed infusion rate.The physician was unable to aspirate fluid from the catheter access port (cap).Surgical intervention was taken to revise the catheter.

• 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 07828
• Manufacturer Contact: karen matis ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 7303761
• MDR Text Key: 101237556
• Report Number: 3010079947-2018-00021
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: 0100810335020099171812281022894
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

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: Physician
• Device Expiration Date: 12/28/2018
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 22894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• 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