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

Model Number	VS-402
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Vasculitis (2004); Thrombosis/Thrombus (4440)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).Ifu was followed.A guidewire was used for insertion of the catheter.It is reported the glue gun would not properly engage.A second kit was opened to complete the procedure.1 segment was treated, and the vein is reported to have closed.It was reported that there were gaps in treatment along the vein.This led to the patient developing thrombophlebitis.The patient was prescribed nsaids and instructed to apply warm compress to the area.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11524274
• Report Number: 9612164-2021-01039
• Device Sequence Number: 3971894
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 59914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention