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

Model Number SP-101

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

Patient Problem Skin Irritation (2076)

Event Date 12/07/2016

Event Type  Injury  

Event Description

It was reported that the physician used a venaseal closure system during a procedure to treat the great saphenous vein.It was reported that the vein closed 5cm distally from sfj to proximal tibial gsv.Tumescent infiltration, local anaesthesia and transducer compression were used.It was reported that approximately 4 hours after the procedure the patient experienced skin irritation or burn.The patient did not complain of pain during active treatment nor was skin irritation noted.There were no other devices utilized.The skin irritation was reported to be located mid/distal postero medial femoral skin area.There were some skin colour changes (redness) at the level of right mid-distal epifacial segment of gsv.The physician concluded it was an allergic reaction, so he used anti allergic drugs.The irritation was still present the day after the treatment, at the time of the first report.A couple of weeks after the event it was reported that it has resolved.The patient is reported to be in a good condition.

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: 6225293
• MDR Text Key: 63950443
• Report Number: 3011410703-2017-00001
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 12/08/2016

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: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: 12/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 58