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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 NCEUP22520X
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the hypotube 61cm distal to the strain relief. The hypotube material was oval and jagged on both sides of the detachment site. Kinks were evident on the hypotube on both sides of the detachment site. The balloon folds were expanded and there was blood in visible in the balloon. No deformation was noted to the distal tip. The inner lumen could not be verified with a 0. 015 inch mandrel most likely due to hardened blood in the guidewire lumen. No other damage evident to the remainder of the device. 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 resolute onyx rx coronary drug eluting stent to treat a lesion located in the right coronary artery (rca). The device was inspected with no issues noted. The lesion was pre-dilated. 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. The device was not kinked or re-straightened during use. It was reported that the device detached at the catheter during delivery through the vessel. The detached portion of the stent catheter was removed safely by trapping it with a coronary balloon inside a turnpike guide extension catheter and removing from the patient. The patient was reported to be alive with no further injury. A nc euphora rx balloon catheter returned along side the resolute onyx with a detachment on the hypertube. During analysis, it was noted that a kink was identified on both sides of the hypertube. The balloon folds were expanded and blood was visible in the balloon.
 
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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 
EI  
091708734
MDR Report Key10968374
MDR Text Key220453722
Report Number9612164-2020-04814
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
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 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/11/2022
Device Model NumberNCEUP22520X
Device Catalogue NumberNCEUP22520X
Device Lot Number219489931
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 Received01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2020
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: 12/08/2020 Patient Sequence Number: 1
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