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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number EUP2515X
Device Problems Difficult to Remove (1528); Failure to Deflate (4060)
Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)
Event Date 04/07/2021
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 euphora rx ptca balloon catheter to treat a lesion exhibiting 99% stenosis and an acute myocardial infarction located in the right coronary artery (rca). 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. The device was attempted to be used to pre-dilate the lesion, however inflation difficulties occurred. It was stated that dilation was performed at approximately 6atm, but dilation could not be confirmed by fluoroscopy, so deflation was attempted, however it is unknown whether the balloon deflated. The balloon was inflated again and contrast agent was only confirmed in the front portion of the balloon. It was reported that due to poor visibility of the balloon during imaging deflation was attempted but deflation could not be achieved. It was stated that the balloon could not be pulled out, so it was removed for the whole system. It was also reported that ventricular tachycardia (vt) occurred and changed to ventricular fibrillation (vf) due to difficulty in removing the balloon caused by no deflation, however this recovered with direct cardioversion. When the patient recovered, the procedure was started over. One nc euphora ptca balloon catheter was then used to pre-dilate the lesion and two resolute onyx coronary drug eluting stents were implanted. The procedure was completed without issue.
 
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Brand NameEUPHORA 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11684626
MDR Text Key245983753
Report Number9612164-2021-01515
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143480
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
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEUP2515X
Device Lot Number221064833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2020
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: 04/19/2021 Patient Sequence Number: 1
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