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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number EUP2020X
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)
Event Date 05/22/2020
Event Type  malfunction  
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 non-calcified lesion exhibiting 90% stenosis located in the mid ramus. The device was inspected with no issues noted. Negative prep was not performed. 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 euphora balloon burst/leaked during first balloon inflation at 18 atm. There was no medical or surgical intervention needed to prevent a permanent impairment of a function. The event did not lead to or extend patient hospitalization. The patient was reported to be alive with no injuries.
 
Manufacturer Narrative
Additional information: the lesion was non-tortuous. It was reported that the euphora balloon leaked. The device was not moved or repositioned in the lesion while inflated. It was later stated that the balloon leak caused perforation to the anterior descending artery. The perforation was treated by reversing heparin with protamine. Another balloon was then placed at the perforation site until the hole was sealed. The patient was reported to be alive with no further injuries. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameEUPHORA 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 Key10084975
MDR Text Key192398899
Report Number9612164-2020-01958
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAR
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,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2021
Device Catalogue NumberEUP2020X
Device Lot Number218638578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2019
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: 05/25/2020 Patient Sequence Number: 1
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