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

Catalog Number VS-402

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/18/2016

Event Type  Injury  

Event Description

The physician used the venaseal to successfully treat the great saphenous vein as per ifu.It was reported that an extension into the deep common femoral vein was treated.It was non-occlusive and the vein was partially compressible.

Manufacturer Narrative

The venaseal closure system was not returned for evaluation.Two sonograms were provided sonogram 1 is from the day of the procedure; and sonogram 2 is from the following day.Sonogram 1 shows the junction of the left great saphenous vein and the common femoral vein.In sonogram 1 the extension of the adhesive is visible in the common femoral vein.In sonogram 2 the adhesive is not visible in the common femoral vein.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MORRISVILLE; 951 aviation parkway; morrisville NC
• Manufacturer (Section G): MORRISVILLE; 951 aviation parkway; morrisville NC
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5955452
• MDR Text Key: 54879097
• Report Number: 2183870-2016-00602
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• 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,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Device Lot Number: 43112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 64