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U.S. Department of Health and Human Services

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

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MEDTRONIC EUPHORA CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number EUP2515X
Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Failure to Advance (2524)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
A 2. 5 by 15 mm euphora balloon was kinked in packaging and was unable to be advanced over the 0. 014 wire. Never went in the body.
 
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Brand NameEUPHORA
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC
chris harrold
8200 coral sea st ne # mvs74
saint paul MN 55112
MDR Report Key6724382
MDR Text Key80438922
Report Number6724382
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEUP2515X
Device Lot Number212621115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2017
Event Location Hospital
Date Report to Manufacturer06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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