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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cellulitis (1768); Hypersensitivity/Allergic reaction (1907)

Event Date 11/01/2018

Event Type  Injury  

Event Description

Pt had venaseal (cyanoacrylate adhesive vein closure) procedure performed by dr (b)(6) on (b)(6) 2018.Dr (b)(6) had not performed this procedure previously in any other pts.Pt had prior history of venous insufficiency, including previous deep vein thrombosis, a population which was not studied with this product.Pt suffered numerous complications, including hypersensitivity reaction and cellulitis.Dr (b)(6) provided little to no aftercare instructions and provided poor f/u care upon pt complaints of adverse reactions.Emergency dept admission was required to address numerous complications.

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 8042497
• MDR Text Key: 126553501
• Report Number: MW5081100
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/01/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 30 YR
• Patient Weight: 116