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

Catalog Number SP-101

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

Patient Problems Itching Sensation (1943); Phlebitis (2004)

Event Date 06/03/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records could not be conducted because the lot number was not provided.No component of the vena seal closure system was returned for evaluation.Five photographs of the patient¿s both legs were provided for review.The swelling and red skin colour change could be seen in the photographs of both of the patient legs.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used the venaseal successfully to treat the gsv and ssv as per ifu.The physician treated both legs, 4 segments were treated and closed, total length approx.90 cm with 3.2 cc of cyanoacrylate used.Approx.2 months¿ post procedure the patient presented with itching and a red skin colour change, changing to a blue colour in both legs after standing for 1 hour.This symptom was considered to be phlebitis and the patient was treated with nsaids and antibiotics.The symptoms were resolved after a few days.The patient has no known allergies.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7078445
• MDR Text Key: 93563208
• Report Number: 9612164-2017-01708
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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
• Patient Age: 17 YR
• Patient Weight: 60