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

Catalog Number UNK-PLY-VENASEAL

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

Patient Problems Inflammation (1932); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 04/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

The venaseal procedure was conducted by on (b)(6) 2019.The patient started to notice redness on the treated area, pain and tightness in the upper leg area and the vein was very sensitive to the touch on (b)(6) 2019.The patient was prescribed a course of steroids on (b)(6) 2019 which seemed to help but a few days after finishing the course of steroids the redness returned.A second course of antibiotics was initiated on (b)(6) 2019 and that treatment has finished.It was reported that approx.3 days post finishing the prescribed steroid medication the patient noticed that the treated area was looking red again.The patient was prescribed a third dose of steroids and has since completed them.The patient has reported that the vein line is a faint dark color, and not the red it was reported to have been in the past.

Manufacturer Narrative

The physician has consulted with another md who has recommended treating with topical cortisone and referring the patient to an allergist.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): 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: 8632746
• MDR Text Key: 145800598
• Report Number: 9612164-2019-01896
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-VENASEAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• 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