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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
Model Number EUP3015X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use two euphora rx ptca balloon catheters to treat a moderately tortuous lesion exhibiting 50% stenosis located in the mid left anterior descending (lad) artery. There was no issues noted to the packaging. There was no issues noted when removing the device from the hoop. The device was not inspected. The lesion was not pre-dilated. Excessive force was not used during delivery. It was reported that the device detached at the catheter during advancement through the guide catheter. It was stated that the patient had instent restenosis in the mid lad. A wire was passed through the lesion and oct was performed. It was stated that the oct or wire may have got caught on the previously implanted stent. It was reported that a non-medtronic balloon caught the vessel after ballooning. It was indicated that the non-medtronic balloon broke from the shaft in the guide catheter during removal. The 3. 0 x 15 euphora rx was then attempted to be used to trap the parts of the non-medtronic balloon and it also broke at the shaft. A snare was used to trap the 3. 0 x 15 euphora rx (lot number 218711917) and all pieces were removed from the patients body. It was noted that several other balloons were used including a 2. 5 x 15 euphora rx. There was no issues noted with the 2. 5 x 15 euphora rx. No further patient injury was reported. A 3. 0 x 15 euphora balloon catheter from another lot was returned for evaluation. The returned device, lot number 217889500 has a detachment on the shaft.
 
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 Key9903377
MDR Text Key192023393
Report Number9612164-2020-01425
Device Sequence Number1
Product Code LOX
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,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2021
Device Model NumberEUP3015X
Device Catalogue NumberEUP3015X
Device Lot Number217889500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2019
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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