MEDTRONIC EUPHORIA BALLOON 21432182

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for MEDTRONIC EUPHORIA BALLOON 21432182 manufactured by Medtronic.

Event Text Entries

[122032664] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5080148
MDR Report Key7914169
Date Received2018-09-26
Date of Report2018-09-25
Date of Event2018-08-15
Date Added to Maude2018-09-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDTRONIC EUPHORIA BALLOON
Generic NameBALLOON DILATATION, CATHETER
Product CodePON
Date Received2018-09-26
Model Number21432182
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2018-09-26

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