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

Model Number 11823

Device Problems Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint number: (b)(4).Mfr 3010079947-2018-00040 is related to mfr 3010079947-2018-00039.

Event Description

It was reported that the intrathecal pump was observed loose and the catheter was kinked.Surgical intervention was taken to revise the pump pocket and unkink the catheter.

Manufacturer Narrative

(b)(4).Mfr 3010079947-2018-00039 is related to mfr 3010079947-2018-00040.

Event Description

On (b)(6) 2018, a healthcare professional reported the physician determined that the pump was highly mobile and was likely to kink the catheter.Therefore, the pump pocket was revised.The catheter was not kinked as initially reported.

• 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: 7304541
• MDR Text Key: 101236206
• Report Number: 3010079947-2018-00039
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: 0100810335020099171702071020725
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2017
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 20725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2015
• 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
• Patient Outcome(s): Required Intervention