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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number EUP1506X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/25/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It is reported that a launcher guide catheter and euphora balloon catheter became detached in-vivo. The launcher guide catheter was removed from packaging, inspected and prepped per ifu with no issues noted. The euphora device was inspected before use with no issues noted. The physician was attempting to treat a lesion in the native circumflex and saphenous vein graft to rca. A radial approach was used. There was no calcification, stenosis or degree of vessel tortuosity in the radial. The physician used a series of catheters including al1 and jr35, three balloons, and three resolute stents. It is reported that the launcher "folded on itself after a kink". The launcher was torqued during use. A non-mdt angioplasty wire and a euphora balloon catheter were used to attempt to straighten the fold, and after manipulation, the launcher and euphora sheared off above the wrist to above the elbow. The launcher sheared off midway on the shaft. The euphora sheared off at the distal shaft. Excessive force was not used. Patient went to surgery, and two incisions were needed to extract the pieces. All fragments of the launcher and euphora were successfully removed from the patient. The radial artery was in good condition after the removal of the equipment. The physician put a tr band in place. Patient was discharged the next day with radial and ulnar pulses intact on the right arm. Patient is reported to be fine post-op.
 
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Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key5675345
MDR Text Key100770656
Report Number9612164-2016-00477
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2017
Device Catalogue NumberEUP1506X
Device Lot Number209921516
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2016 Patient Sequence Number: 1
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