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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 NCEUP3012X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2019
Event Type  malfunction  
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. The device was inspected with no issues noted. The lesion was pre-dilated. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that a balloon burst/leak occurred during the first inflation at 17-18 atm. No patient injury was reported.
 
Manufacturer Narrative
Product analysis # (b)(6): device was returned for evaluation. The device returned with blood visible in the balloon and inflation lumen. The balloon failed negative prep. Upon visual inspection of the device, there was a large radial tear to the proximal balloon bond. The balloon material was jagged and uneven at the tear site. It was not possible to inflate the device. No other damage evident to the remainder of the device 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 Key9568143
MDR Text Key175111896
Report Number9612164-2020-00161
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
Report Date 03/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/22/2021
Device Model NumberNCEUP3012X
Device Catalogue NumberNCEUP3012X
Device Lot Number218763529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
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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