• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number UNK-CV-GWY-EUPH RX
Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)
Patient Problems Nausea (1970); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 02/23/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a physician used a euphora rx balloon dilatation catheter for pre-dilatation as part of an angioplasty procedure on the proximal and mid rca including the ostium. Approx. 7 days later, the patient was presented to another hospital complaining of chest pain. Angio was performed and foreign matter was noted in the vessel. It was reported to be the protective sheath of the euphora rx balloon and was successfully removed with a snare. The patient was safely discharged home. The hospital staff commented that this was not a product issue. It was completely user error.
 
Manufacturer Narrative
Patient presented to another hospital complaining of severe chest pain and nausea.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,mx
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,mx
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key5553953
MDR Text Key100765449
Report Number9612164-2016-00318
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,Followup
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-GWY-EUPH RX
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 Received06/27/2016
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: 04/07/2016 Patient Sequence Number: 1
-
-