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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
Model Number NCEUP3015X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); Vascular Dissection (3160)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a lesion located in the proximal left anterior descending (lad) artery. The device was inspected with no issues noted. The device was pre-dilated. The device did not pass through a previously deployed stent. It was reported that the balloon burst at 18 atms. It was also reported that balloon deflation difficulties occurred at the lesion site. The device was removed from the patient using a snare. The patient was reported to be alive with no injury.
 
Manufacturer Narrative
An image provided is of the distal section of a poba device with a detachment of the balloon and the inner member. The balloon appears to have detached at proximal balloon bond, this indicates the balloon ruptured at this location. Blood is visible in the balloon. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: mildly tortuous lesion exhibiting 70% stenosis located in the distal left anterior descending (lad) artery. Negative prep was performed with no issues noted. The lesion was pre-dilated with another balloon, and then stented using a resolute onyx (2. 5mm) coronary drug eluting stent. Post dilation was carried out using the nceup3015x device. Resistance was noted when advancing the nceup3015x and excessive force was not used. The nceup3015x was not moved or repositioned in the lesion while inflated. Deflation difficulties were noted on the second inflation. There were no difficulties on previous inflations. The balloon deflated slowly and blood returned when aspirating from the inflation lumen. It was stated that the mid lad had a dissection proximal to the implanted onyx stent as a result of the nceup3015x balloon rupture. This dissection required implantation of another stent. The nceup3015x sheared off in the right radial artery and was removed using a gooseneck snare. The concentration of contrast/saline solution used was approximately 3:1. 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 Key10024911
MDR Text Key189974076
Report Number9612164-2020-01767
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2021
Device Model NumberNCEUP3015X
Device Catalogue NumberNCEUP3015X
Device Lot Number218902614
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 Received06/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/11/2019
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: 05/05/2020 Patient Sequence Number: 1
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