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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,

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MEDTRONIC MEXICO NC EUPHORA RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number NCEUP3012X
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a nc euphora balloon to treat a moderately calcified, non tortuous lesion, with 95% stenosis in the left main (lm) coronary artery. There was no damage noted to the device packaging. There were no issues noted when removing the device from the protective hoop. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was not pre-dilated. The device did pass through a previously-deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. The device was not kinked and restraightened during use. It was reported that the balloon catheter was fractured during advancement through the guide catheter. The detached portion of device did not remain in patient. The nc euphora and wire were used to pulled the fractured balloon out. No patient injury was reported.
 
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Brand NameNC EUPHORA RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
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 
EI  
091708734
MDR Report Key12433171
MDR Text Key270086499
Report Number9612164-2021-03448
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCEUP3012X
Device Lot Number222550755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2021
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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