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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUPHORA BALLOON, PERCUTANEOUS CORONARY

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MEDTRONIC EUPHORA BALLOON, PERCUTANEOUS CORONARY Back to Search Results
Model Number EUP2515X
Device Problems Difficult to Remove (1528); Material Rupture (1546); Mechanical Jam (2983)
Patient Problems Death (1802); Pericardial Effusion (3271)
Event Date 10/06/2020
Event Type  Death  
Event Description
During percutaneous balloon angioplasty of the pt's right coronary artery, the medtronic euphora 2. 5mm x 15mm balloon ruptured and could not be retrieved from the vessel. Other balloons and stents were used to try and free the stuck initial balloon but with no success. Pt was sent to icu on balloon pump support and pressors after the wire refused surgical intervention for the pt. Pt also had developed a small pericardial effusion which was drained and the drain was left in place upon transfer to the icu. Dnr. Pt expired on (b)(6) 2020.
 
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Brand NameEUPHORA
Type of DeviceBALLOON, PERCUTANEOUS CORONARY
Manufacturer (Section D)
MEDTRONIC
MDR Report Key10644223
MDR Text Key210984329
Report Number10644223
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEUP2515X
Device Catalogue NumberEUP2515X
Device Lot Number220002176
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/06/2020
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/07/2020 Patient Sequence Number: 1
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