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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 Problems Break (1069); Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
Event Type  malfunction  
Event Description
During a coronary intervention, physicians were attempting to insert a balloon into the body to perform a coronary angioplasty.The balloon catheter broke before entering the body.This occurred three times with three balloons, all the same brand and size.We used another balloon that worked.
 
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Brand Name
NC EUPHORA
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway
minneapolis MN 55432
MDR Report Key8451286
MDR Text Key139821123
Report Number8451286
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 Other Health Care Professional
Type of Report Initial
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNCEUP2512X
Device Lot Number216906363
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/19/2019
Event Location Hospital
Date Report to Manufacturer03/26/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age27740 DA
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