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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number NCEUP4012X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Occlusion (1984)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one resolute onyx des was used to treat the lad. 26 months post index procedure during a revascularisation procedure one nc euhpora balloon catheter and one resolute onyx des were used and plaque shift occurred and was treated with implant of a resolute onyx des.
 
Manufacturer Narrative
Additional information: the investigator assessed the event was not related to index device or anti-platelet medication. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction: patient recovered. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: investigator assessed the event was unlikely related to index device or antiplatelets medication. Correction: event date (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNC EUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9503725
MDR Text Key173966172
Report Number9612164-2019-05280
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141090
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 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/21/2019
Device Model NumberNCEUP4012X
Device Catalogue NumberNCEUP4012X
Device Lot Number218014275
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 Received02/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2017
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: 12/20/2019 Patient Sequence Number: 1
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