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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, PERCUTANEOUS

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCSP4012X
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use one nc euphora rx ptca balloon catheter to treat a moderately tortuous, severely calcified lesion exhibiting 95% stenosis located in the proximal rca. The device was inspected with no issues. Negative prep was performed with no issues. It was reported that the device failed to cross the lesion. The device was also used approximately 6 weeks post expiry date. The patient is reported to be alive with no injury.
 
Manufacturer Narrative
It was subsequently reported that the lot number was initially reported incorrectly. The correct lot was then provided, and the device was used prior to its expiry date. The device was an nc sprinter rx ptca balloon catheter, not an nc euphora. 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, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo cucapah #10510del
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo cucapah #10510del
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8277027
MDR Text Key134073914
Report Number9612164-2019-00311
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K141090
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 02/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2019
Device Catalogue NumberNCSP4012X
Device Lot Number212293709
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 Received02/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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