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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number EUP2512X
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
An attempt was made to use a euphora rx balloon catheter. The device was inspected with no issues noted. Negative prep was performed with no issues. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that balloon deflation difficulties occurred, the balloon would not deflate at the lesion site. It was stated that after multiple attempts the balloon had to be removed inflated. The patient was alive with no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameEUPHORA 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13534951
MDR Text Key290565639
Report Number9612164-2022-00621
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEUP2512X
Device Lot Number223088706
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2021
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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