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

Lot Number 42354

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

Patient Problem Cellulitis (1768)

Event Date 10/28/2016

Event Type  Injury  

Event Description

It was reported that the physician used the venaseal to treat the great saphenous vein as per ifu, with no issue noted.It was reported that the patient returned post op presenting with bi-lateral red cellulitic symptoms on the treated leg.

Manufacturer Narrative

Evaluation summary: no component of the vena seal kit was received for evaluation.Two photographic images were received.The first image is of the patient¿s left leg.Areas of redness were noted above and below the knee on the inside of the patient¿s left leg.The second image is of the patient¿s right leg.Areas of redness were noted above and below the knee on the inside of the patient¿s right leg.Additional information received: no topical medication was administered.The patient has no known allergies.The patient's condition took a couple of weeks to resolve.

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.

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; north carolina NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville; north carolina NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6173068
• MDR Text Key: 62313774
• Report Number: 2183870-2016-00709
• 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,Followup
• Report Date: 12/16/2016

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 Expiration Date: 03/31/2017
• Device Lot Number: 42354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/16/2016
• Supplement Dates FDA Received: 02/10/2017; 03/06/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2015
• 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): Other