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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2020
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 tortuous, moderately calcified lesion located in the mid right coronary artery (rca). The device was inspected with no issues noted. Negative prep was performed with no issues noted. The device was being used to pre-dilate the lesion. It was stated that resistance was not noted to be more difficult than other tortuous lesions. It was reported that the balloon burst during first inflation at 16 atm. It was stated that the device was not moved or repositioned while inflated. No patient injury was reported.
 
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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 Key10091224
MDR Text Key192397701
Report Number9612164-2020-01992
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/03/2021
Device Catalogue NumberEUP2020X
Device Lot Number219060251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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