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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
Model Number NCEUP3012X
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Myocardial Infarction (1969); Obstruction/Occlusion (2422)
Event Date 06/13/2021
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 one nc euphora rx ptca balloon catheter to treat a non tortuous and non calcified lesion in the distal rca with less than 20% stenosis. The device was inspected with no issues. Negative prep was performed with no issues noted. The lesion was 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. It was reported that removal difficulties were experienced following the second balloon inflation at 18atm. The balloon was ruptured from the shaft, with flow obstruction as a result and shutdown of the rca with transmural ischemia. It was reported that the patient had possible myocardial infraction. The patient is reported to be alive with 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 Key12065306
MDR Text Key258300412
Report Number9612164-2021-02481
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCEUP3012X
Device Catalogue NumberNCEUP3012X
Device Lot Number221816206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2021
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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