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

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.

• Brand Name: MEDTRONIC EUPHORIA BALLOON
• Type of Device: BALLOON DILATATION, CATHETER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 7914169
• MDR Text Key: 122032664
• Report Number: MW5080148
• Device Sequence Number: 1
• Product Code: PON
• 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: 09/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 21432182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• 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): Death
• Patient Age: 81 YR
• Patient Weight: 60