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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,

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Model Number NCEUP4012X
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Insufficient Information (4580)
Event Date 11/10/2021
Event Type  Injury  
Event Description
An attempt was made to use a nc euphora rx ptca balloon catheter to treat a moderately calcified, non tortuous lesion with 100% chronic total occlusion (cto) in the mid left main (lm) 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 pass through a previously-deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. The device was being using for the proximal optimization technique (pot) of a non mdt stent from the left main to the lad. It was reported that a balloon burst occurred during first inflation at 18 atm for 10 sec when inflated in the proximal portion of the stent. Difficulties removing the device were encountered. It was stated that the ruptured balloon seemed to be caught on the stent struts at the distal portion of the balloon or tip, preventing the balloon from being removed. It was also reported that the shaft of the balloon became separated at the hypotube transition. The balloon was captured using a gooseneck snare. After the shaft was removed, there was no bleed back which was suggested to be due to a clot. The whole system was removed and the detached balloon was on the catheter part that came off the guide catheter. No further patient injury was reported.
 
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,
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key12983425
MDR Text Key282105374
Report Number9612164-2021-04814
Device Sequence Number1
Product Code LOX
UDI-Device Identifier00643169396227
UDI-Public00643169396227
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCEUP4012X
Device Catalogue NumberNCEUP4012X
Device Lot Number222923210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/10/2021
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: 12/13/2021 Patient Sequence Number: 1
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