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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. EUPHORA CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number EUP2510X
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Event Description
Balloon dilation catheter being used in heart to dilate blood vessel. First inflation at 6 atm, no problem, second inflation at 7 atm, no problem, inflation at 8 atm revealed a leak of dye from the balloon indicating a rupture. Balloon deflated, and catheter removed. Second catheter required to complete procedure. Physician inspected the area where the faulty balloon failed and determined no part of the balloon remained in the patient. Physical inspection of balloon did not reveal any missing parts.
 
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Brand NameEUPHORA
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway
minneapolis MN 55432
MDR Report Key8792991
MDR Text Key151121338
Report Number8792991
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 07/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEUP2510X
Device Lot Number217347818
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2019
Event Location Hospital
Date Report to Manufacturer07/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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