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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a procedure one nc euphora balloon catheter was attempted to be used. When the balloon was inflated, it ruptured in the patient's artery. Parts of the balloon were retained in the patient's artery and were removed.
 
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Brand NameNC EUPHORA 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 Key12215912
MDR Text Key263106339
Report Number9612164-2021-02843
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/23/2021 Patient Sequence Number: 1
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