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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 NCEUP3508X
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the distal shaft material was torn. Stretching was evident to the inner member. The support wire was exposed. Deformation was evident to the guidewire entry port and the material was protruding outwards. Damage was evident to the inner member along the entire length of the distal shaft, the material appeared to be protruding outwards. The damage appeared to spiral along the inner member. Slight deformation was evident to the distal tip. No other damage was evident to the remainder of the device. An a device image was provided. The image is of the distal section of a device. On magnification of the image, it is evident the support wire is exposed and the distal shaft material is torn. If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure a nc euphora ptca balloon catheter was used to post dilate a resolute onyx stent which was implanted to treat a moderately tortuous, non calcified lesion located in the mid left anterior descending artery (lad). There was no damage noted to the packaging. No damage was noted prior to use in the patient. Negative prep was not performed. The lesion was not pre-dilated. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that deformation of the catheter occurred, stretching was noted at the catheter. The device was removed. The patient is reported to be alive with no injury.
 
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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 Key8644090
MDR Text Key146233673
Report Number9612164-2019-01971
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 05/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Catalogue NumberNCEUP3508X
Device Lot Number217198767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2019
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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