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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 EUP2512X
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2020
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 one euphora rx ptca balloon catheter to treat a non-tortuous, non-calcified lesion ex hibiting 95% stenosis located in the mid left anterior descending (lad) artery. There was no difficulty removing the stylette from the balloon prior to insertion. The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that inflation difficulties occurred during balloon inflation at 8atm. It was also reported that balloon deflation difficulties occurred following first inflation and the device would not deflate at the lesion site. The balloon was removed very slowly from the patient while inflated at 8 atm with no difficulties encountered, however removal difficulties were encountered when removing the balloon through the 6 french guide. It was noted that the length of the stylette appeared shorter than normal. The patient was reported to be alive with no injury.
 
Manufacturer Narrative
Product analysis summary: a stopcock was attached to the luer of the device. A kink was noted on the hypotube, immediately distal to the strain relief. A stylette was loaded in the device. The distal tip was positioned at the hook of the stylette. The balloon was partially inflated. There was hardened contrast in the balloon material. The proximal balloon bond was necked. The core wire was kinked. It was not possible to perform inflation and deflation testing due to the condition of the proximal balloon bond. The distal tip was cut longitudinally and the stylette was removed without issue. There was no residue visible on the stylette. There was no other damage evident to the remainder of the device. 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 Key10306769
MDR Text Key199862863
Report Number9612164-2020-02677
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 09/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/07/2022
Device Model NumberEUP2512X
Device Catalogue NumberEUP2512X
Device Lot Number219236809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2020
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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