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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 07/05/2018

Event Type  Injury  

Event Description

Pt's body rejected venaseal used to close down greater saphenous vein for venous insufficiency.Diagnosis or reason for use: venous insufficiency.The product is not compounded; the product is not otc product.

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUSION, VASCULAR PERMANENT
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 8042463
• MDR Text Key: 126548097
• Report Number: MW5081095
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 51