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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 EUP2012X
Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problem Vascular Dissection (3160)
Event Date 07/03/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that a euhpora rx balloon catheter was attempted to be used to pre-dilate a mildly tortuous, severely calcified lesion with chronic total occlusion in the mid rca. There was no damage noted to the device packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was pre-dilated using a 1. 25x12 mm sprinter legend balloon. The euphora device did not pass through a previously deployed stent. Resistance was encountered when advancing the device, excessive force was not used. It is reported that the euphora device was advanced and when inflated above rated burst pressure (16 atms) the balloon burst. The euphora balloon was used for several inflations in the lesion area. It burst on the last inflation. A sudden drop in pressure noted on the inflation device. A dissection was noted at the balloon burst site. A 2. 5x12 mm euphora device was then delivered and inflated for 1 minute. There was an angiographical improvement and it was confirmed that there was no perforation. No further patient complications reported for this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7731101
MDR Text Key115368788
Report Number9612164-2018-01888
Device Sequence Number0
Product Code LOX
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
Report Date 10/05/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/23/2019
Device Catalogue NumberEUP2012X
Device Lot Number215320118
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/23/2018
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: 07/30/2018 Patient Sequence Number: 1
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