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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 EUP2510X
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
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-tortuous, non-calcified lesion located in the distal right coronary artery (rca). There was no damage noted to the packaging. There was no issues noted when removing the device from the hoop. The device was not inspected. 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 inflation difficulties occurred during the first balloon inflation. The balloon would not inflate. It was stated that there was a hole in the distal part of the shaft close to the balloon, through which air was escaping from. The device was not moved or repositioned in the lesion while inflated. The distal shaft (hole) was inside the patient during balloon inflation. The device was withdrawn from the patient as it would not inflate. It was stated that when the device was removed from the patient an attempt was made to inflate and the hole was noted. The same inflation device was used successfully with other devices. There was no medical or surgical intervention needed to prevent permanent impairment of a function. The event did not extent patient hospitalisation. The patient was reported to be alive with no injury.
 
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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 Key10401112
MDR Text Key203719371
Report Number9612164-2020-02984
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCI
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 10/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/23/2022
Device Catalogue NumberEUP2510X
Device Lot Number219351487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2020
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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