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

Model Number VS-402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Swelling (2091); Claudication (2550)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was using venaseal occluding device during procedure to treat 50cm of the great saphenous vein (gsv).The lumen was flushed prior to use.Ifu was followed.A guide wire was used for the insertion of the catheter.It was reported that two hours post procedure, patient began to feel pain which was steadily gotten worse.Follow up two days post procedure and everything looks great, deep scan carried out.Patient returned five days post procedure limping, now more pain and itchiness.A deep scan was carried out again, everything normal but very tender to palpation with the probe.There is edema and induration along the gsv but minimal erythema.Skin is itchy but patient can not scratch because it is painful.Physician wrapped leg in coban which seemed to help.Patient was put on medrol dose pack and allegra.No further patient injury reported.

Manufacturer Narrative

Image review: one image was received for evaluation.The image shows slight redness on the patient thigh.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the venaseal was used to treat the right great saphenous vein.The volume of adhesive administered is unknown.Sterile techniques were followed during the procedure.The vein is reported to have closed.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: 9824172
• MDR Text Key: 189579947
• Report Number: 9612164-2020-01146
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 57234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Date Device Manufactured: 10/31/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 66