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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
Model Number EUP2512X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
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 a euphora rx balloon catheter to treat a severely calcified and severely tortuous lesion exhibiting 95% stenosis located in the mid left anterior descending artery (lad). The device was inspected with no issues noted. Negative prep was performed. The lesion was pre dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. The device was not kinked and restraightened during use. It was reported that the balloon ruptured occurred and upon inspection outside the patient body, it was noticed that portion of the balloon was detached. The physician believed that it was left in the target vessel. Patient was sent to cabg and had a heart open bypass.
 
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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 
EI  
091708734
MDR Report Key11326998
MDR Text Key232159675
Report Number9612164-2021-00635
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEUP2512X
Device Catalogue NumberEUP2512X
Device Lot Number220727967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2020
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: 02/15/2021 Patient Sequence Number: 1
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