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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 EUP2025X
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
There was no damage noted to the packaging of the euphora balloon. There were no issues noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was not performed. The lesion was pre-dilated. No abnormalities reported in relation to anatomy. The balloon was inflated to 8 atms with no issues noted. During the second inflation again to 8 atms, contrast leakage was viewed under floro and on removal of the balloon from the patient, there seemed to be a hole in the balloon. No resistance had been encountered when advancing the device. No injury reported.
 
Manufacturer Narrative
Additional information: the euphora balloon was being used to treat an occluded lesion in the distal lad. A coronary angiography revealed chronic occlusion of the ostial lad. Prior to use of the euphora balloon, two non-mdt stents were successfully deployed. Final flow timi iii was achieved so it was decided to end the procedure. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 Key7747090
MDR Text Key116233224
Report Number9612164-2018-01954
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCI
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,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/11/2019
Device Catalogue NumberEUP2025X
Device Lot Number213827795
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/15/2017
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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