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 Problem Reaction (2414)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient received a venaseal treatment of the left leg on (b)(6) 2018 with great results.The patient then had a venaseal treatment of the right leg on (b)(6).The physician accessed below the knee.The tip of the catheter was mid to distal thigh.A short segment of the gsv was treated from mid-thigh to just below the knee.Sfj was not part of the treatment as the proximal portion was previously treated.Compression of the gsv was carried out.The last aliquot was delivered at the black laser marker on the delivery catheter.The patient was prescribed valium prior to procedure.It was reported that the patient has had a reaction on the right leg, 3 days post the procedure on this leg in the form of a high fever, pain and hardening of tissue at the insertion site.3 days post procedure, the patient was prescribed antihistamine hydroxyzine 5mg, 4 times day for 3 days and ibuprofen 600mg 3 times day for 5 days.5 days post procedure the patient was further prescribed cephalexin 500mg twice a day for five days.The access site was reported to have healed and looks good.

• 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: 7969356
• MDR Text Key: 123831614
• Report Number: 9612164-2018-02765
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• 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: 71 YR