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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
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the euphora rx ptca balloon catheter survey results from an interventional cardiologist in practice 5 years. In the past 12 months the physician has used euphora rx 122 times and euphora rx (other intermediate sizes) were used the following complications adverse events/effects were encountered using the euphora rx product over the last 12 months: 1 infection event occurred that was related to a pre-existing condition or comorbidity. The following device complaints were encountered in procedure when using the euphora rx product over the last 12 months: 1 deflation difficulty which had clinical/patient impact. The deflation difficulty was noted to have been caused by the patients condition.
 
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Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
tijuana
Manufacturer (Section G)
MEDTRONIC MEXICO
tijuana
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9271066
MDR Text Key189909450
Report Number9612164-2019-04599
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
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

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