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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 NCEUP3512X
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure, one nc euphora rx ptca balloon catheter was used to treat a severely tortuous, non calcified lesion exhibiting 70% stenosis located in the mid left anterior descending (lad) artery. The device was inspected with no issues noted. The lesion was pre-dilated. The device did pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that the nc euphora rx balloon used during the procedure was over 2 months expired. It was stated that the use by dates were incorrectly read and was noticed after the procedure was completed. The patient was reported to be alive with no injuries.
 
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Brand NameNC EUPHORA 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 Key9859089
MDR Text Key192192940
Report Number9612164-2020-01254
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2020
Device Catalogue NumberNCEUP3512X
Device Lot Number214666885
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/04/2018
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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