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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
Model Number EUP2020X
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
One euphora rx balloon catheter was attempted to be used to treat a tortuous lesion. It was stated that the device was originally used as a rail to get the guide up the coronary tree through the radial artery. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The device did not pass through a previously deployed stent. The balloon was inflated to 1-2 atms to help get the guide up. It was reported that the balloon appeared to separate. The physician took another balloon and was able to trap the material and take it out through the guide while wedged in a launcher guide catheter. It was also reported that difficulties were noted when removing the balloon following inflation. No further patient injury reported.
 
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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 Key10695781
MDR Text Key211869301
Report Number9612164-2020-03981
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEUP2020X
Device Catalogue NumberEUP2020X
Device Lot Number219783114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2020
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: 10/19/2020 Patient Sequence Number: 1
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