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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 EUP3530X
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)
Event Date 11/07/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An nc euphora rx ptca balloon catheter was used during a procedure to treat a severely calcified lesion in the right coronary artery (rca). There was no damage noted to the packaging. The device was removed from the hoop with no issues. The device was inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that the balloon did not deflate at all and could not be removed, attempts with an additional gw and snare were unsuccessful, while trying to retrieve the balloon the catheter tore/fractured up from the balloon but the balloon remains still inflated in the rca. The patient had an mi and was not stable.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation summary: the device returned with a detachment on the hypotube 33. 5cm distal to the strain relief and a detachment 87cm distal to the strain relief on the transition shaft. The hypotube material was oval and jagged on both sides of the detachment site. The transition shaft material at the detachment site was jagged and uneven. Kinks were evident on the hypotube 6. 2cm proximal to the detachment site and 2. 3cm distal to the detachment site. Deflation testing could not be performed as the most distal detached section of the device did not return for analysis. No other damage evident to the remainder of the device. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The relevant device which was previously reported as an nc euphora, is a 3. 5x30mm euphora rx ptca balloon catheter. The rca was stented during a previous pci and was now occluded. The stenosis was crossed with a guidewire, and was dilated in several steps. A 3. 0x20mm euphora balloon was used successfully. The 3. 5x30mm euphora was first inflated to 7 atm and could not be deflated. Then the balloon was inflated to 20 atm to try to burst the balloon with no success. While attempting different manipulations and pullback to retrieve the balloon, the catheter detached from the balloon. The small mi occurred because of a thrombus in a side branch. 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 Key9314744
MDR Text Key166141139
Report Number9612164-2019-04731
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K141090
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,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2019
Device Catalogue NumberEUP3530X
Device Lot Number214444488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2017
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: 11/13/2019 Patient Sequence Number: 1
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