MAUDE Adverse Event Report: COVIDIEN LLC 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 Reaction (2414)

Event Date 11/16/2016

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

The physician used a venaseal closure system during procedure for treatment of the great saphenous vein (gsv).The lumen was flushed prior to use.The ifu was followed.Local anesthesia and transducer compression was used.Two (2) segments of the vessel were treated.The vein closed.Procedure was completed.Following treatment of venous disease with venaseal, the patient had a fever, and body aches and severe redness surrounding the treated vein.The physician prescribed erythromycin which resolved the redness.Physician felt this is an indication that the patient had strep.The patient¿s condition is improving.

Manufacturer Narrative

Additional information received: it was reported that the patient¿s symptoms began within 72 hours of the procedure, before the 72 hour dvt rule out ultrasound.It was reported that the symptoms cleared up with the antibiotic, erythromycin, given.It is unknown how long after the patient began the antibiotic that it resolved.It was reported that the physician did not culture the infection however it resolved with the erythromycin antibiotic which is used for strep infections.Consequently, the physician is confident that it was strep the patient contacted and that the infection was unrelated to the venaseal.

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 LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6173452
• MDR Text Key: 62338601
• Report Number: 3011410703-2016-00022
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided; 12/20/2016
• Supplement Dates FDA Received: 01/17/2017; 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