MAUDE Adverse Event Report: OMNISEAL; ANGIO-SEAL

Device Problem Device Slipped (1584)

Patient Problems Chest Pain (1776); Pain (1994)

Event Date 02/01/2018

Event Type  Injury  

Event Description

Entered emergency room with chest pain admitted.Next day the cardiologist explained a stress test was not a guarantee i wouldn't have heart attack but a heart catheter was 100 percent.Said it wasn't anything to worry about.That afternoon after the catheter i told the nurse my right leg hurt.Sent home.Couldn't use leg without severe pain.I called the cardiologist and physician assistant finally sent me for a leg ultrasound.Tech said no blood clots and sent me home.Three days later cardiologist office called and said no blood clots, was not from procedure.I went to my primary doctor and she sent me for a 3 hour test to check arteries and veins.Tech said no blood clots and i was sent home.Following day my dr said to go to er - i had a 3" blood clot in leg artery.Omni groin seal slipped into leg and blocked the artery.I suffered with horrible leg pain for exactly a week.I was told i could have lost my leg or worse.

• Brand Name: OMNISEAL
• Type of Device: ANGIO-SEAL
• MDR Report Key: 7464836
• MDR Text Key: 106830996
• Report Number: MW5076797
• Device Sequence Number: 1
• Product Code: MGB
• 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: 04/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 53 YR
• Patient Weight: 61