MAUDE Adverse Event Report: MORRISVILLE VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Phlebitis (2004)

Event Date 03/12/2013

Event Type  Injury  

Manufacturer Narrative

Publication journal title: sapheon: the solution? authors: lawson, j; gauw, s; vlijmen, cv; pronk, p; gaastra, m; mooij; wittens, cha journal: phlebology year: 2013 pages: 2 - 9.

Event Description

This study was carried out at the (b)(6) hospital in (b)(6).In this study, 14 venasealtm procedures were performed on 12 patients.There were no serious adverse events.Side-effects were self-limited thrombophlebitis accompanied with pain after four procedures starting between two and seven days postoperative.Only one patient needed pain medication.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6263045
• MDR Text Key: 65203533
• Report Number: 3011410703-2017-00005
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention