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

Catalog Number SP-101

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

Patient Problems Itching Sensation (1943); Patient Problem/Medical Problem (2688)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a venaseal procedure carried out on (b)(6) 2019.The lumen was flushed prior to use.Local anesthesia was used with no compressions.The procedure was completed without incident.There was no alleged product issue.Post the procedure, the patient complained of calf itching.The physician prescribed cortisone and anti-histamines.

Manufacturer Narrative

Additional information: the patients right leg was treated.5 ml of cyanoacrylate was used for the procedure.Lesion length was 30cm.The itching reported appeared only along partial area of the length treated.Update the patients symptoms swelling, itching and redness in the right leg were experienced in part of the treated area have disappeared after the prescribed medication was taken.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: 8499693
• MDR Text Key: 141470418
• Report Number: 9612164-2019-01269
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

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 Expiration Date: 10/31/2020
• Device Catalogue Number: SP-101
• Device Lot Number: 53387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/20/2019
• Date Device Manufactured: 10/31/2018
• 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