MAUDE Adverse Event Report: COVIDIEN 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 Local Reaction (2035)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

Photographic analysis: two photographic images of the blister of the patient¿s treated right leg were received.The photographs confirm a blister wound on a vena seal treated right leg.

Event Description

A venaseal device was used for a successful vein closure procedure of the great saphenous vein (gsv), performed on (b)(6) 2016.It was reported that the patient developed a local cutaneous inflammation on his leg, located about 10 cm from the insertion site on (b)(6) 2016.The locally formed blister was pierced and treated with ¿betaisodona¿ wound gauze.It was reported that after a few days, it became necessary to perform a cut-down procedure at the inflammation site to treat it.The patient was also reported to have expressed out some adhesive content from the blister site.Patient's condition is reported to be stable and slowly improving.

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
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6353375
• MDR Text Key: 68154857
• Report Number: 3011410703-2017-00023
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

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: 11/30/2017
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: 42362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: 01/25/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 11/25/2015
• 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
• Patient Age: 53 YR
• Patient Weight: 90