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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number UNK-CV-GWY-EUPH RX
Device Problem Burst Container or Vessel (1074)
Patient Problems Atherosclerosis (1728); Death (1802); Gastritis (1874); Myocardial Infarction (1969)
Event Date 08/15/2018
Event Type  Death  
Manufacturer Narrative
Ref: mw5080148. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient presented with hypertension, chest pain and cough. He became more short of breath and it was decided to place an intra aortic balloon. There were small specks of blood noted in the clear tubing from the balloon pump indicating a leak. The balloon pump and balloon were replaced. After multiple pumps were changed the patients condition continued to decline and the patient was taken back to the operating room to change out the balloon, at that point it was noted that the retrieved balloon was ruptured. It is indicated that this balloon could be a euphora rx ptca balloon catheter. It was reported that the patient expired.
 
Manufacturer Narrative
The intra aortic balloon was a non-medtronic device. In autopsy, the cause of death is severe coronary artery disease; severe atherosclerosis, hemorrhagic gastritis, and the myocardial showed a large area coagulative necrosis. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The balloon rupture occurred in the post-care unit. It was initially indicated that this balloon could be a euphora rx ptca balloon catheter, however it was subsequently reported that the ruptured balloon was likely a non medtronic balloon pump catheter. However, it is likely that a euphora balloon was used in the patient while in the cath lab. The head nurse in the cath lab reported that there were no euphora balloon ruptures. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8054934
MDR Text Key126655941
Report Number9612164-2018-03127
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-GWY-EUPH RX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2018 Patient Sequence Number: 1
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