MAUDE Adverse Event Report: SAPHEON/MEDTRONIC VENA SEAL CLOSURE SYSTEM; CLOSURE, WOUND, ADHESIVE

Model Number SP-101

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

Patient Problem Reaction (2414)

Event Date 03/28/2015

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

It was reported that the patient had a venaseal procedure of the gsv.Patient was prepped with rectogesic placed topically along gsv prior to case.Venaseal case was performed via ifu, with no procedural drift.2 days post procedure, patient called the doctor to report rash on inner thigh.The doctor is unsure if the allergic reaction is to the cyanoacrylate or rectogesic.Oral and topical ant-inflammatory prescribed for a week.The mild inflammation responded well to oral and topical anti-inflammatory which is consistent with non-specific mild inflammation of the cutaneous and subcutaneous tissue.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: CLOSURE, WOUND, ADHESIVE
• Manufacturer (Section D): SAPHEON/MEDTRONIC; 951 aviation pkwy; suite 900; morrisville NC 27560
• Manufacturer (Section G): SAPHEON/MEDTRONIC; 951 aviation pkwy; suite 900; morrisville NC 27560
• Manufacturer Contact: mary haufek ; 951 aviation pkwy; suite 900; morrisville, NC 27560 ; 7633987000
• MDR Report Key: 5476088
• MDR Text Key: 39532094
• Report Number: 3011410703-2016-00001
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/31/2015

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: 07/01/2016
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: 38756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2014
• 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: 00054 YR
• Patient Weight: 27