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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCEUP4006X
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/20/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation: the balloon returned inflated with crystallised residue present inside the balloon. It was not possible to deflate the balloon there was no stretching evident to the distal shaft or balloon bond. No other damage visible to the catheter. The device was placed in the waterbath to disperse the residue in the balloon in order to aid inflation. Inflation testing was performed, but balloon failed to inflate. The device was inspected for any stretching on the distal shaft however no stretching was evident. The delivery system was placed in waterbath to loosen any potential blockages. Upon second inflation, balloon again failed to inflate. To determine location of blockage, delivery system was cut at the distal shaft 21. 6cm proximal to the distal tip. A make shift luer was attached to the distal potion of the device which included the distal shaft and the balloon. Using a make-shift luer, the balloon was successfully inflated at 12 atms, at 13 secs. A 0. 014 inch mandrel was advanced through the hypotube with no resistance noted. There appeared to be a blockage in the transition tube, as no water was seen exiting when pressurisation was applied. The transition shaft was cut away to determine the location of the blockage. Crystallized contrast residue was visible under the transition tubing material and on the support wire. The device was placed into the waterbath to disperse residue. Upon second attempt water was successfully flushed through hypotube, with no issues noted. This confirmed the blockage to be due to the crystallised residue. The guidewire lumen patency was verified with a 0. 015 inch mandrel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Image review: three still images were provided for review. The first image captures the complaint device with inflation contrast visible in the balloon. The second image captures what appears to be the complaint device in vivo. However this cannot be confirmed as the quality of the image is poor. The third image captures the complaint device and the packaging label on the device. The manufacturing lot number is not visible in the photo. The reported deflation difficulties cannot be confirmed by the images received. (b)(4).
 
Event Description
It was reported that the physician was attempting to use a nc euphora rx balloon to treat a non-tortuous mid vessel lesion. No damage was noted to device packaging and no issues removing the device from the hoop/tray. The device was inspected and negative prep was performed with no issues noted. During advancement of the balloon resistance was reported but no excessive force was used. It was reported that the balloon was being used and was inflated post stent dilatation, however was unable to be deflated after the first inflation. Removal difficulties were also reported. The nc euphora balloon was removed after several attempts. There was an attempt to perforate the balloon using a wire. No patient injury reported.
 
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Brand NameNC EUPHORA 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 Key7185171
MDR Text Key116385744
Report Number9612164-2018-00059
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCEUP4006X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
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: 01/12/2018 Patient Sequence Number: 1
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