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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 EUP2515X
Device Problem Leak/Splash (1354)
Patient Problem Intimal Dissection (1333)
Event Date 12/17/2016
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: numerous kinks and stretching were visible on the distal shaft. The device returned deflated with blood and residue present inside the inflation lumen and balloon. Negative prep did not detect a leak possibly due to the residue in the inflation lumen. The device was placed in a waterbath to disperse the residue. On removal of the device negative prep confirmed the presence of a leak. On pressurization of the device a leak was detected; a short radial tear was visible on the working length of the balloon. The balloon material was jagged and uneven along the leak site. (b)(4).
 
Event Description
It was reported that the physician was attempting to use a euphora rx balloon to treat a moderately calcified and slightly tortuous proximal lad lesion. No damage noted to device packaging and no issues were noted when removing the device from the hoop/tray. The device was inspected and negative prep performed with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device to the lesion. It was reported that the device was inflated in the rca once with no issues. It was then delivered to the lad and inflated once. The balloon started losing pressure at 13 atms. The device was not moved or re-positioned prior to the burst. After the case, when the physician removed and attempted to re-inflate the balloon outside the body. He noticed a pin point hole that saline shot out of with substantial pressure. It was not a longitudinal split. The balloon caused a dissection. The physician put in two stents to cover. Patient is doing well.
 
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, 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 Key6253486
MDR Text Key64886376
Report Number9612164-2017-00048
Device Sequence Number1
Product Code LOX
UDI-Device Identifier00643169560024
UDI-Public00643169560024
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
Type of Report Initial,Followup
Report Date 12/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2018
Device Catalogue NumberEUP2515X
Device Lot Number212232491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
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: 01/16/2017 Patient Sequence Number: 1
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