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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 NCEUP3520X
Device Problems Deflation Problem (1149); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure a nc euphora rx ptca balloon catheter was used to treat a non calcified, non tortuous distal right coronary artery. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre dilated. The device did not 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 balloon was inflated to 20atm during subsequent inflation and could not be deflated at the lesion site. The patient is alive with no injury. It is indicated from images that the balloon and catheter shaft are deformed.
 
Manufacturer Narrative
The procedure was not a complex pci case. A non-medtronic wire was used. No issues were noted during inflation. 2 inflations were performed before deflation difficulties occurred. One at 12atm and one at 20atm. The physician tried to deflate again and then removed the balloon. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation summary: a kink was evident on the hypotube. The proximal balloon bond and the distal shaft immediately proximal to the balloon bond was torn. The proximal marker band was exposed. The material was jagged and uneven at the tear site. The distal section of the balloon was bunched around the tip. There was no damage evident to the distal tip. Deformation was evident to the exchange joint. Deformation was evident to the transition shaft. It was not possible to perform deflation testing due to the condition of the returned device. There was no other damage evident to the remainder of the device. Image review: images provided are the same images taken at different angles. The image are of a poba device. A section of the distal shaft appears to be torn. Blood is visible in the balloon and the torn section of the distal shaft. If information is provided in the future, a supplemental report will be issued.
 
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, 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 Key8715375
MDR Text Key148543092
Report Number9612164-2019-02444
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSN
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,Followup,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2020
Device Catalogue NumberNCEUP3520X
Device Lot Number214838994
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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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