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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 EUP2010X
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a euphora rx balloon for pre-dilation treatment of a moderately calcified lad lesion. No damage was noted to device packaging. There were no issues removing the device from the hoop. The device was inspected prior to use and negative prep was performed. There were no issues when removing the stylet and protective sheath. Resistance was noted in the initial stage when the non-medtronic guidewire was passed through the tip portion of the balloon. Inflation difficulties were reported as the balloon could only partially inflate at nominal pressure. It was not possible to deflate the balloon at the lesion site. It was reported that it was difficult to remove the device from the patient due to the device being partially inflated. Intervention was attempted to deflate the partially inflated balloon but it was difficult. The balloon was removed, and the procedure was completed using a non-medtronic product. The patient had no problem post procedure and no patient injury was reported.
 
Manufacturer Narrative
Additional information: the device did not pass through a previously deployed stent. Small to medium tortuosity reported slight resistance reported product analysis summary: the device returned with balloon inflated. Contrast was visible in the balloon and inflation lumen. Deformation was evident to the distal tip. Stretching was evident to the balloon bond. The device passed negative prep. It was not possible to inflate or deflate the balloon due to stretching of the balloon bond. No other damage was 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 Key8207932
MDR Text Key131773839
Report Number9612164-2019-00006
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2019
Device Catalogue NumberEUP2010X
Device Lot Number213556116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/05/2017
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: 01/02/2019 Patient Sequence Number: 1
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