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

Model Number 11823

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device is being investigated at the manufacturing site.When the investigation is complete, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the patient had recently fallen and decided to visit the pain management facility to check on the pump.A catheter access port (cap) study was performed and contrast dye was observed in the lumbar region, away from the catheter tip.The physician suspected the catheter was damaged and performed a catheter replacement on (b)(6) 2016.There were no patient effects reported.The damaged catheter was returned for evaluation.

Manufacturer Narrative

Device evaluation summary: the returned catheter was subjected to visual examinations, as well as, functional and simulated use testing.The evaluation determined that the device appeared damaged due to some other mechanical influence unrelated to the pump therapy.Based on the investigation, the reported event was confirmed.(b)(4).

Event Description

It was reported that the patient has had extensive back surgery and has a lot of hardware, including screws and cages for a spinal fusion, in the lumbar region.

• 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: jill schweiger ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 5477750
• MDR Text Key: 39978939
• Report Number: 3006803715-2016-00039
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: 01008103350200991717101510
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/15/2017
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 21164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2015
• 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