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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hematoma (1884); Rash (2033)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Journal title exit site complications following cyanoacrylate glue endovenous ablation of incompetent truncal veins for chronic venous insufficiency.Https://doi.Org/10.1016/j.Jvscit.2020.08.010.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing case reports of "exit site complications following cyanoacrylate glue endovenous ablation of incompetent truncal veins for chronic venous insufficiency." medtronic venaseal was used in the patient described in case 3.The patient underwent a right great saphenous vein (gsv) venaseal ablation for c2s disease.The patient presented with a small hematoma and rash around the puncture site 11 days post procedure, which resolved with etericoxib and chlorpheniramine.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11642222
• MDR Text Key: 244679264
• Report Number: 9612164-2021-01404
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• 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: 61 YR