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

Catalog Number VS-402

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.1 photo was provided for analysis.In that photo redness and bruising was noted on the leg of a patient.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used venaseal to treat a patient¿s great saphenous vein (gsv).The ifu was followed.No issue was experienced during the procedure apart from the physician having trouble gaining access low.It was reported that this was the doctors first venaseal case, and he had trouble seeing the sheath and the tip of catheter before delivering the adhesive.3-4 weeks post the procedure, the patient reported experiencing pain, a rash-like area, soreness in the mid-thigh and pain in the inner thigh.Medrol dose pack was prescribed for the hypersensitivity.

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): 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: 7706395
• MDR Text Key: 114577855
• Report Number: 9612164-2018-01811
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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