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

Model Number 11823

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a catheter occlusion occurred.A catheter access port (cap) dye study was performed; however, the physician was unable to aspirate out of the cap.The physician decided to explant the catheter.The physician observed "tissue" clogging all of holes of 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: 7276754
• MDR Text Key: 100267260
• Report Number: 3010079947-2018-00031
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: 0100810335020099171808131022431
• 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: 01/19/2018

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: 08/13/2018
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 22431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2016
• 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