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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 NCEUP22515X
Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure it was intended to use one nc euphora device to treat a mildly tortuous, a mildly calcified with 20% stenosis in the mid left anterior descending (lad) artery. No damage was noted to the packaging, no issues were noted when removing the device from the hoop/tray. The device was not inspected, negative prep was not performed. The lesion was pre-dilated, the device did not pass through a previously deployed stent, no resistance was encountered and no excessive force was used. It was reported that inflation difficulties were observed and a balloon burst, leak or catheter leak was identified during balloon inflation. The burst/leak was identified on the first inflation after 10 atms pressure was applied to the device. The device was replaced by another medtronic product. The patient is reported to be alive with no injury.
 
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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 Key12459357
MDR Text Key271003123
Report Number9612164-2021-03499
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCEUP22515X
Device Lot Number221678696
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
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

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