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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 11/22/2022

Event Type  Injury  

Event Description

A patients great saphenous vein (gsv) was treated using a venaseal closure system.The catheter was not flushed prior to use.The ifu was followed.A guidewire was used for insertion and placement.Compression was not used.The sfj was bent and treatment was performed at a distance of 5cm or more from the sfj.It was reported during the follow-up one week later that the patients edema became severe on the treated foot.No pain. dvt in the deep vein around the abdomen and multiple dvts were scattered around the knee area.The patient was urgently hospitalized.

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 ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15892113
• MDR Text Key: 304592065
• Report Number: 9612164-2022-04511
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

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 Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/01/2022
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female