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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. NC EUPHORA¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC, INC. NC EUPHORA¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number NCEUP2512X
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
Early 50¿s male with history of coronary artery disease and 3 stents with recent chest pain and elevated troponin level. Procedure: cardiac catheterization and percutaneous intervention, stents and balloon angioplasty. When the medtronic nc euphora was used, the shaft broke during procedure. Removed intact without known harm to the patient. Unfortunately, the device was not saved. Manufacturer response for nc euphora, nc euphora (per site reporter): will obtain.
 
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Brand NameNC EUPHORA¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy
minneapolis MN 55432
MDR Report Key13087304
MDR Text Key282776527
Report Number13087304
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCEUP2512X
Device Catalogue NumberNCEUP2512X
Device Lot Number223034487
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2021
Event Location Hospital
Date Report to Manufacturer12/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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