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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 EUP2515X
Device Problem Deflation Problem (1149)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use one euphora rx ptca balloon catheter to treat a lesion in the circumflex (cx) artery. The device did not pass through a previously deployed stent. It was reported that the device failed to deflate at the lesion site following the first inflation. The balloon was ruptured in order to deflate it.
 
Manufacturer Narrative
Product analysis summary: a stopcock and syringe were attached to the luer of the device. The device returned deflated. Deformation was evident to the tubing immediately proximal to the balloon bond, the tubing appeared to have inflated. The balloon bond was measured and confirmed to be 1mm, with spec being 1mm-2mm. The device was inflated to nominal pressure of 8atm. The balloon appeared to be curved. The tubing immediately proximal to the balloon bond appeared to have inflated. The device deflated with no issues. There was no damage evident to the remainder of the device. Additional information: there were no issues noted when removing the protective sheath and stylette from the device. The device was not moved or re-positioned in the lesion. No issues noted during inflation of the device. The device failed to deflate at the lesion site following the first inflation. Omnipac contrast 50 ml and 40 ml saline was used. 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 Key8247184
MDR Text Key133037243
Report Number9612164-2019-00185
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 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/06/2019
Device Catalogue NumberEUP2515X
Device Lot Number215585902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2018
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: 01/15/2019 Patient Sequence Number: 1
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