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 Problems Rash (2033); Reaction (2414)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a venaseal treatment was successfully carried out on the great saphenous vein (gsv), as per ifu, on (b)(6) 2018.The patient presented with a full body rash almost 3 weeks later.The patient was treated with medication after seeing an allergist.The rash has responded to the medication.The patient was reported to be doing well.

Manufacturer Narrative

Additional information: approximately 1.3ml of cyanoacrylate (glue) was used in the procedure enough to treat 1 great saphenous vein.Six images were received and reviewed.Image 1 shows redness and bruises on the left side of patient's body.Image 2 shows redness and bruises to patient's left thigh and lower leg.Image 3 shows redness and bruises to patient's right thigh.Image 4 shows redness under patient's neck.Image 5 shows redness on right side of patient's face.Image 6 shows redness on patient's skin - location on patient's body unknown but possibly on patient's hand.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: 7766675
• MDR Text Key: 116524376
• Report Number: 9612164-2018-01995
• 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: 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 Expiration Date: 02/28/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 50430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/29/2018; 08/08/2018
• Supplement Dates FDA Received: 09/26/2018; 10/04/2018
• Date Device Manufactured: 02/13/2018
• 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