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

Model Number VS-402

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

Patient Problem Unspecified Infection (1930)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used the venaseal to treat the short saphenous vein as per ifu.The patient was treated for a stasis ulcer that was contaminated but not infected (no cellulitis) at the time of procedure ((b)(6) 2016).The procedure was completed with no issue noted.It was reported the patient suffered infection post procedure which extended about 6-7 cm from the puncture site and included a tributary vein that also had infected glue.The skin over the tributary vein and surrounding subcutaneous tissues essentially formed an abscess that spontaneously drained.Small plugs of glue and pus came out at the "satellite" site.Patient was treated with oral antibiotics.The physician eventually had to surgically excise the infected vein under general anaesthesia ((b)(6) 2016), by carrying out a left leg incision, draining of skin and subcutaneous tissue and excision of vessels of lower limb veins.There was a small amount of purulent material around glue in distal segment of short saphenous vein tributary at site of satellite infection (cultured); short saphenous vein contained glue that did appear infected.Cultures from the excised vein where tested the results showed the glue grew pseudomonas.The patient is responding to oral cipro, clindamycin 300 mg x 10 days and open wound care.The patient is reported as stable with the wounds healing slowly.

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): COVIDIEN; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560 6228
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6181145
• MDR Text Key: 62593163
• Report Number: 2183870-2016-00723
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 11/28/2016
• Supplement Dates FDA Received: 09/28/2017
• 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