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

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a physician used venaseal to treat a patient during a procedure to treat the great saphenous vein (gsv).The device was prepped as per ifu.The procedure was completed as per ifu.A guidewire was used for the insertion of the catheter.Tumescent infiltration was not utilized.One segment was treated.Local anaesthesia was used.9 days post op, the patient developed a local blotchy erythematous (redness) ascending rash between her knee and groin.It was bright red and tracked upwards along the course of the vein.It was itchy and swollen.Approximately 11 days post op, the patient developed a generalised erythematous macular rash across her whole body involving the arms, waist, neck, shoulders and scalp.It was investigated thoroughly by the allergy team and found the patient has a contact dermatitis allergy to n-butyl-2-cyanoacrylate (i.E.Histoacryl).This event was treated successfully with antihistamines.No further patient injury was reported for this event.

• 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: 8339345
• MDR Text Key: 136140385
• Report Number: 9612164-2019-00517
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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: 02/04/2019
• 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
• Patient Age: 45 YR