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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 EUP2020X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 05/31/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was intended to use one euphora rx balloon to treat a mildly calcified and non tortuous lesion in proximal, mid and distal portions of the lad with 50-70% of stenosis. It was reported that there was no damage noted to the packaging and no issues were identified when removing the device from the hoop. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was not pre-dilated. The euphora rx balloon device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. It was reported that balloon deflation difficulties were encountered as the euphora rx balloon was slow to deflate at the lesion site during subsequent inflation. It was also reported that the euphora rx balloon burst. The balloon had been inflated maybe 2-3 times as routine and nominal pressure was applied prior to the burst occurring. A stent pci was required. The patient is alive with no injury.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12149670
MDR Text Key260964335
Report Number9612164-2021-02687
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEUP2020X
Device Lot Number220928373
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/08/2020
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: 07/12/2021 Patient Sequence Number: 1
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