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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 NCEUP2520X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 05/06/2019
Event Type  Injury  
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 a nc-euphora rx ptca balloon catheter to treat a mildly tortuous, moderately calcified lesion exhibiting 99% stenosis located in the mid obtuse marginal (om). The device was inspected with no issues noted. Negative prep was performed without issue. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. The device was not kinked and re-straightened during use. It was reported that during the first balloon inflation at 12atm a balloon rupture occurred. It was also reported that a detachment occurred at the balloon during removal of the device. The detached balloon was removed from the left main but could not be retracted into the guide catheter. An attempt was made to use a 2. 5x12mm euphora balloon to trap the broken balloon at the end of the guide, however it was instead pushed forward into the left main. The broken balloon was then wired past and a 1. 5x12mm euphora balloon was delivered past the broken balloon. The 1. 5x12mm euphora sc balloon was inflated and the broken balloon was pull ed back into the end of the guide catheter. The 1. 5x12mm euphora sc was then dilated successfully trapping the broken balloon against the end of the guide catheter. The broken balloon, wires and guide catheter were then retracted back to the tip of the radial 6f n on-mdt radial sheath. The broken balloon tip was unable to be retracted into the sheath. An attempt was made to pull the balloon out with the sheath but the broken balloon tip would not come out of the wrist. It was indicated to be stuck in the arteriotomy or in the vessel. A terumo tr band was placed on the radial for successful homeostasis. Right femoral access was then obtained and the pci procedure was successfully completed using a 2. 75x26mm resolute onyx stent. Subsequently, the patient was seen by vascular surgery and setup for surgical removal of the broken balloon. No further injury was reported.
 
Manufacturer Narrative
Image review: photo 1; image is of the distal section of a device. The markerband is visible in the image. Photo 2; image is of the distal section of a device. The markerband is visible in the image. Undetermined accessory equipment can be seen to the left of the distal section of the device. Photo 3; image is of the distal section of a device. The markerband is visible in the image. Undetermined accessory equipment can be seen to the left of the distal section of the device. Photo 4; image of the procedure provided, no relevant information pertaining to the investigation can be identified. Photo 5; image is of the detached section of the balloon placed on a ruler. Photo 6; image of the procedure provided, no relevant information pertaining to the investigation can be identified. Photo 7; image is of a hoop and a delivery system. There appears to be a detachment on the distal shaft. Device evaluation summary: the proximal balloon bond, balloon and distal tip were detached from the device. Dried blood was visible in the balloon. The balloon folds were expanded. The distal shaft material immediately proximal to the proximal markerband appeared to have inflated and then burst. The material was jagged and uneven at the burst site. The inner member was detached and did not return for analysis. 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.
 
Manufacturer Narrative
Correction: a 180 non-medtronic guidewire was used during the procedure. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8615141
MDR Text Key145213452
Report Number9612164-2019-01773
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141090
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 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2021
Device Catalogue NumberNCEUP2520X
Device Lot Number217126005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2019
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: 05/16/2019 Patient Sequence Number: 1
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