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 Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Image review one image was received for review.Per the image, redness and swelling of the patient skin was noted.The clinical complication was noted post procedure examination after the initial procedure was successful.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used a venaseal closure system to treat segments of the great saphenous vein(gsv) on (b)(6) 2019.Ifu was followed during preparation, procedure and post procedure.1.5 ml of adhesive was administered to the vein.The procedure was completed on the day without any issue and 43cm of the gsv were treated.The patient presented to the physician on (b)(6) 2019 with a rash, itching and pain along the treated area.The patient has started taking medrol, topical sarna, zyrtec and tylenol.There is a follow visit scheduled for 2 weeks post this visit.

• 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: 8703121
• MDR Text Key: 148141445
• Report Number: 9612164-2019-02364
• 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: Other
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53926
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Date Device Manufactured: 12/12/2018
• 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
• Patient Age: 69 YR
• Patient Weight: 76