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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 NCEUP37515X
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems Vascular Dissection (3160); Insufficient Information (4580)
Event Date 03/18/2022
Event Type  Injury  
Event Description
An attempt was made to use an nc euphora balloon catheter in a moderately tortuous, moderately calcified lesion in the proximal left main (lm) coronary artery and the left anterior descending (lad) artery. The device was inspected with no issues noted. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force not used during delivery. It was reported that balloon deflation difficulties occurred after post dilation of a stent. The deflation difficulties occurred following the first inflation. Several techniques were made to deflate the balloon including changing the inflation device and attempts to burst the balloon with no success. With slight pressure coming off the balloon, it was possible to pull the balloon out of the stent, while partially inflated, back through the lad, through the lm and into the guide catheter. The whole system was removed together via the radial artery. Post angiogram showed a dissection in the left main. An additional sent was used to treat the dissection. No further 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 Key13962612
MDR Text Key288281418
Report Number9612164-2022-01246
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCEUP37515X
Device Catalogue NumberNCEUP37515X
Device Lot Number223719752
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/31/2022
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: 03/31/2022 Patient Sequence Number: 1
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