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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 EUP27510X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Event Date 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis. There were numerous kinks visible along the hypotube. The balloon and tip material along with the inner shaft markers had detached. The balloon bond was not visible indicating that it had detached along with the balloon material. A section of the inflated distal outer shaft remained. The distal outer material was jagged and uneven at the detachment site. The inner shaft was stretched. The inner shaft material was jagged and uneven at the detachment site. Cine review: four still images were received from the account which appear to show the lesion site in the 1st diagonal. The images do not capture use of the euphora device and therefore do not confirm the reported event.
 
Event Description
It was reported that the physician was attempting to use one euphora rx balloon catheter to treat a lesion in the lad vessel. Lesion exhibited moderate calcification and tortuosity. The device was inspected with no issues noted. Negative prep was performed successfully. Lesion was dilated with the a euphora balloon(2. 75x10). No resistance was noted while advancing to the lesion. It was reported that during first balloon inflation (@ 15 atm) the balloon burst. There was a gradual drop in pressure. The device was not moved or re-positioned in the lesion prior to the burst. Excessive force was not used during delivery. It was reported that the physician encountered difficulty removing the device following the burst. Physician completed the procedure. Patient's status is excellent post procedure, no complications.
 
Manufacturer Narrative
Additional information received: the euphora balloon passed through a previously deployed stent and was placed in the 1st diagonal and inflated for 20 seconds. The physician has confirmed that this was a difficult procedure in trying to retrieve the detached parts however was able to retrieve the detached parts back into the guide catheter without the use of a snare. Patient is doing well. The physician confirmed that parts were removed, pulling a bit higher than usual, then did an angiographic control and saw nothing left in the patient. However there is some risk. Cine image review update: the cine images capture the deployment of the stent and delivery of a balloon device through the stent cell. The images show the poba balloon inflated with no evidence of a burst. The images do not appear to capture the delivery, inflation, burst and subsequent material detachment.
 
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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 Key5797686
MDR Text Key100788495
Report Number9612164-2016-00682
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 07/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2018
Device Catalogue NumberEUP27510X
Device Lot Number210969216
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2016
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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