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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number NCEUP5008X
Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2021
Event Type  Injury  
Event Description
An attempt was made to use an nc euphora rx balloon catheter. The device was inspected, with no issues noted. The device was not kinked and re-straightened during use. It was reported that the balloon detached and was separated from the shaft of the catheter during delivery through the vessel. The balloon could not be fully retracted into the guide catheter. The guide catheter was removed and it was noted that the sheared off partial balloon was found in the mid right forearm in the right radial artery. Further surgical removal of the balloon was required on the next day post the index procedure. No further patient injury was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNC EUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key12810464
MDR Text Key280744730
Report Number9612164-2021-04406
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2022
Device Catalogue NumberNCEUP5008X
Device Lot Number220383523
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2020
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: 11/15/2021 Patient Sequence Number: 1
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