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

Catalog Number VS-402

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

Patient Problem Irritation (1941)

Event Date 02/27/2019

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 was attempting to us a venaseal closure system to treat a short saphenous vein (ssv) lesion in a patient.It was reported that skin irritation or burn occurred ¿ irritation was present all over the body one-week post operation.The physician suspects the keflex may be the antagonist, but difficult to tell.The patient did not complain of pain during active treatment.The irritation is still present - the patient got some redness 24 hours after treatment with pain.Visited the emergency room and was put on keflex for suspected cellulitis.Patient then broke out in systemic hives and redness.The keflex was discontinued.Placed on an oral steroid, prednisone.No further patient injury reported, and the vein was closed.Local anesthesia was used, hand compression was used.

Manufacturer Narrative

Additional information: a total of approximately 0.07cc of glue was used to treat an estimated 15cm of vein.There were no challenges or deviations related to the location of the catheter tip prior to delivery of adhesive or compression which was used as per ifu.If information is provided in the future, a supplemental report will be issued.

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: 8408032
• MDR Text Key: 138386066
• Report Number: 9612164-2019-00826
• 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,Followup
• Report Date: 07/02/2019

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: 03/06/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 07/01/2019
• Supplement Dates FDA Received: 03/29/2019; 07/02/2019
• 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