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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 EUP2015X
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2020
Event Type  malfunction  
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 mildly tortuous, mildly calcified lesion with 20% stenosis in the distal rca. The device was inspected with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that the balloon would not deflate at the lesion site. The issue occurred after the first inflation. It was stated that the balloon was inflated and deflated again to remove the balloon and that it seemed as if the balloon had moved from its original position. No 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 Key10338647
MDR Text Key200809543
Report Number9612164-2020-02799
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/03/2022
Device Catalogue NumberEUP2015X
Device Lot Number219630149
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 Received08/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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