MAUDE Adverse Event Report: MEDTRONIC, INC. VENASEAL CLOSURE SYSTEM; AGENT OCCLUSION, VASCULAR, PERMANENT

Device Problem Protective Measures Problem (3015)

Patient Problems Pain (1994); Phlebitis (2004); Reaction (2414)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Venaseal closure system used to close saphenous vein.Product failed to close vein, product created severe phlebitis, product created severe allergy, significant pain caused.

• Brand Name: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT OCCLUSION, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 7818923
• MDR Text Key: 118457444
• Report Number: MW5079423
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 85