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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 EUP2520X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problems Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Event Date 06/10/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: the euphora rx balloon catheter was intended to be used to treat a lesion in the rca. There was a thrombus/tight 95% lesion in the mid right coronary artery. The rca was tortuous and calcified. When the deflation difficulty occurred, the physician inflated the balloon to about 18 atm which popped the balloon proximally, so they could remove it. It was reported that there was some calcification that damaged the balloon and caused a little dissection proximally, but no rupture of the artery. The physician decided to stent the most distal portion of the lesion. A 2. 5 x 26mm resolute integrity drug eluting stent was deployed at 14 atm. Then a 3. 0 x 26mm resolute integrity drug eluting stent was deployed at 16 atm, with excellent result. The 1 rv marginal branch was jailed, but there was no difference to the flow in the branch, and the branch was left wide open. There was no evidence of any real complications due to stent implantation. It is reported that the ruptured balloon did not seem to make any clinical difference in the long run. Evaluation summary: the stylette did not return in the device. Proximal balloon bond stretched. A section of the inflation lumen surrounding the balloon bond had been inflated and had burst. A longitudinal tear was evident along the inflation site. The inflation lumen material was jagged and uneven at the tear site. Distal tip stretched and deformed. The balloon could not be inflated due to the burst on the inflation lumen. Image review the images capture a coronary angiogram (cag) of the left coronary system showing a cto of the proximal lcx. No treatment was captured on the images for this vessel. A lesion site is visible in the rca. The attempted delivery and inflation of the euphora 2. 5x20mm device is evident. A section of the inflation lumen proximal to the proximal inner shaft marker is inflated; most likely the proximal balloon bond. A dissection is then visible proximal to the site of the balloon inflation. There are no images capturing the reported burst or removal of the euphora balloon. Two unidentified stents are then deployed at the site of the dissection. The dissection is then resolved. 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
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use euphora rx balloon catheter to treat a lesion in the lcx. There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray. There was some difficulty experienced when removing the protective sheath/packaging stylette from the device but the stylette was removed. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was not pre-dilated. The device did not pass through a previously-deployed stent. No resistance encountered when advancing the device. No excessive force used during delivery. No difficulties were noted during inflation of the device. It was reported that there were balloon deflation difficulties were encountered. The device would not deflate at the lesion site. 50%/50% concentration of contrast/saline were used by the physician. The issue occurred on the first inflation. The physician inflated the balloon to 23 atm to burst the balloon so they could remove it. The ruptured balloon caused a dissection which was treated with two stents. The physician completed the procedure with euphora 2. 5 x 20 rx (212633097). The physician stated that the lesion was heavily calcified which may have caused an issue with the balloon and that there was a cleft of calcium at the lesion site. Patient is alive.
 
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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 Key6700134
MDR Text Key100920431
Report Number9612164-2017-00866
Device Sequence Number1
Product Code LOX
UDI-Device Identifier00643169560031
UDI-Public00643169560031
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/19/2019
Device Catalogue NumberEUP2520X
Device Lot Number212633097
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3136-2017

Patient Treatment Data
Date Received: 07/11/2017 Patient Sequence Number: 1
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