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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MEDTRONIC EUPHORA SC BALLOON DILATION CATHETER PTCA BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO S. DE R.L. DE CV MEDTRONIC EUPHORA SC BALLOON DILATION CATHETER PTCA BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3.0MM X 20 MM
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2020
Event Type  malfunction  
Event Description
Euphora ptca balloon had inflation/deflation problems. Had to be withdrawn from pt partially inflated causing loss of wire and guide catheter position. Fda safety report id# (b)(4).
 
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Brand NameMEDTRONIC EUPHORA SC BALLOON DILATION CATHETER PTCA BALLOON
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
MDR Report Key9636891
MDR Text Key176775841
Report NumberMW5092551
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2021
Device Model Number3.0MM X 20 MM
Device Catalogue NumberEUP 3020X
Device Lot Number218537232
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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