MAUDE Adverse Event Report: MEDTRONIC VASCULAR VENASEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Device - venaseal closure system-ce mark, procedure: closure of left leg's greater saphenous vein due to circulation problems.Reaction: severe allergic reaction, lower left limb swelling, skin harden and swollen.Severe itching in the vein.

• Brand Name: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3576 unocal place ; santa rosa CA 95403
• MDR Report Key: 7809610
• MDR Text Key: 118154233
• Report Number: MW5079358
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 84