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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
Model Number NCEUP32515X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Date 10/19/2020
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 mildly tortuous, moderately calcified lesion exhibiting 95% stenosis located in the mid left anterior descending (lad) artery. The device was inspected with no issues noted. The device did not 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 balloon deflation difficulties occurred and the device would not deflate at the lesion site. It was stated after trying numerous times to deflate the balloon with the inflator and syringes, the balloon had to be overinflated and burst for removal. Total inflation time in the lad was 5 minutes. The patient was reported to be alive with no further injuries.
 
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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 Key10725207
MDR Text Key212685403
Report Number9612164-2020-04066
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/10/2022
Device Model NumberNCEUP32515X
Device Catalogue NumberNCEUP32515X
Device Lot Number220538004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2020
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: 10/23/2020 Patient Sequence Number: 1
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