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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 EUP2015X
Device Problem Deflation Problem (1149)
Patient Problem Transient Ischemic Attack (2109)
Event Date 04/21/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis: damage to the distal tip was evident. A 0. 015 inch patency mandrel could not be fully loaded through the inner lumen due to hardened blood and/or contrast. The balloon material was noted to be pulled over the tip material, most likely due to the removal of the inflated device. The balloon bond was stretched and necked. The guide wire entry port was stretched. The transition shaft was twisted 9. 5cm proximal to the guide wire entry port. The transition shaft was slightly pinched 1. 5cm proximal to the guide wire entry port. The length of the transition shaft was measured,the distal shaft was measured. The effective length of the device was measured and met specification. The device was placed in a water bath to disperse residue present in the inflation lumen and balloon. On removal of the device from the water bath, attempts were made to inflate the device but these were unsuccessful. Images: the returned cardiogram images shows a blockage of the lad vessel. The images show the presence of two guidewires in the vessel prior to use of the poba device. The images show the attempt to dilate the poba device. The images also appear to show the attempt to deflate the balloon, there was contrast still present in the proximal portion of the balloon which appeared to slow to exit the balloon. Further images show the two guidewires still present in the vessel and a stent being positioned in the vessel. The vessel appeared to be resistant to concentric stent deployment. Further images show the crossing of the deployed stent with a balloon. The final image shows one guidewire present in the vessel. The vessel still appears to be narrowed. (b)(4).
 
Event Description
The physician intended to use a euphora balloon. The target lesion was in the lad, the lesion exhibited little tortuosity, little calcification and 90% stenosis. The device was removed from packaging, inspected and negative prep was performed. No issues were noted. No difficulties noted when removing the protective sheath / packaging stylette from the device. Device was not moved or repositioned in the lesion. No issues noted during inflation of the device. Deflation difficulties were noted after the first inflation, the balloon failed to deflate at the lesion site. The physician had to remove it across the lad risking coronary dissection. Resistance was not encountered and excessive force was not used. The device did not pass through a previously-deployed stent. The patient suffered a transient ischemic attack, associated with this event. Patient status post procedure is alive with no injury.
 
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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 Key5643044
MDR Text Key100770492
Report Number9612164-2016-00445
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/13/2017
Device Catalogue NumberEUP2015X
Device Lot Number210279785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2015
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: 05/10/2016 Patient Sequence Number: 1
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