MAUDE Adverse Event Report: CARDIAC CATHETER

Device Problem Device Inoperable (1663)

Patient Problem Low Cardiac Output (2501)

Event Date 02/11/2016

Event Type  Injury  

Event Description

The pt reported a f/u to his previous ae; "btw, i am all clear medically now so if my help is needed feel free to call on me." f/u to previously reported ae from 01/21/2016: "my friend, my catheterization went well today, i have very minimal artery closure, not an issue at all.Guess all the tuna salad sandwiches i had for lunch over the years, and skipping hamburgers paid off! what i do have that gives me only 44% heart output flow is a muscle issue.This as a result of having a failure of one of my three electrical channels that run down the surface of the heart.At that time 10 years ago, they told me up in a (b)(6) hospital that it was not a problem, as you have two more channels there and you don't need all three.Turns out now that this impacts the heart muscle over a long period of time and caused my muscle problem now.Right now i will be taking medicine for treatment.If my pressure goes to a low and dangerous number at some point, the correction will be installing a pacemaker device.The doctor says i will be fine by saturday to fly to (b)(6) and keep my appointments at (b)(6) there.

• Brand Name: CARDIAC CATHETER
• Type of Device: CARDIAC CATHETER
• MDR Report Key: 5442053
• MDR Text Key: 38445939
• Report Number: MW5060230
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR