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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
Catalog Number EUP3515X
Device Problems Burst Container or Vessel (1074); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2016
Event Type  malfunction  
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 the physician was attempting to use an euphora balloon to post-dilate a severely tortuous and mildly calcified lesion between lmt - lcx which exhibited 90% stenosis after deployment of a non-mdt stent. The device was removed from its packaging and inspected with no issues noted. Negative prep was performed successfully. The lesion was pre-dilated twice at 14 atms for 10 seconds using the same euphora balloon with 50-70% stenosis remaining. It was reported that resistance was encountered when advancing the device and excessive force was used during delivery. As it was inserted for the second time for post-dilation , it did not pass through the lesion site and it was removed outside of the patient body. Then, inflation was carried out with another small-diameter bc (detail unknown). As it was inserted for post-dilation for the third time, reflux of blood was noted and it was recognized as ruptured. A new euphora device (same model) was used to continue the procedure. No patient injury reported.
 
Manufacturer Narrative
Evaluation summary: the distal tip was damaged. The device was placed in a 37 degree celsius waterbath for 48 hours to disperse the hardened blood and contrast in order to facilitate balloon inflation. During the analysis the device failed negative prep. Pressure was applied to the device and liquid was seen exiting the balloon, con firming the presence of a leak. A pin hole leak was present on the proximal end of the balloon working length. The leak site was jagged and uneven. Lead in scratches were evident distal to the leak site.
 
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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 
091708734
MDR Report Key5772117
MDR Text Key100788568
Report Number9612164-2016-00651
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2017
Device Catalogue NumberEUP3515X
Device Lot Number209837433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2015
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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