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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC EUPHORIA BALLOON BALLOON DILATATION, CATHETER

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MEDTRONIC MEDTRONIC EUPHORIA BALLOON BALLOON DILATATION, CATHETER Back to Search Results
Model Number 21432182
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Chest Pain (1776); Death (1802); Respiratory Distress (2045)
Event Date 08/15/2018
Event Type  Death  
Event Description
Intra-aortic balloon pump kept alarming frequently displaying a list of potential problems. While the pt's norepinephrine needs increased nursing, machine rep, and physicians were trouble shooting the situation. There were small specks of blood noted in the clear tubing from the balloon pump indicating a leak. After further physician discussions, a replacement of the balloon and a balloon pump is decided. Replacement of balloon was quick but a ruptured balloon was pulled out. On (b)(6) 2018 rt and physician decided to change out the balloon pump to see if the pump is the problem. In july biomed evaluated the machine for functionality, battery replaced, and connections changed. Machine did indicate a tubing leak. Ekg no wave changes, hgb, stable and k+ pending. Cxr showed the balloon showed it higher than the previous cxr echo completed showing ef 15%. Balloon pump still needed for cardiogenic shock. After multiple pumps were changed, and a pt's declining condition, the pt was taken back to the operating room to change out the balloon. At that point it is noted that the retrieved balloon is ruptured. On (b)(6) 2018 an (b)(6) y/o presented to the ed with htn, chest pain, and cough. Cardiac enzymes serial testing started. He became more short of breath and eventually intubated. A cardiovascular surgeon is consulted for emergent coronary artery bypass surgery but the pt was deemed too high at risk and percutaneous revascularization approach taken. He went to the cath lab where an intra-aortic balloon pump is placed. Pt transferred to icu.
 
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Brand NameMEDTRONIC EUPHORIA BALLOON
Type of DeviceBALLOON DILATATION, CATHETER
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7914169
MDR Text Key122032664
Report NumberMW5080148
Device Sequence Number1
Product Code PON
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21432182
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/26/2018 Patient Sequence Number: 1
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