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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCSP4012X
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: the device was being used to post-dilate a newly deployed medtronic stent (model unknown). No damage was done to the artery walls when the stent was removed using the nc sprinter balloon catheter. The balloon did not get stuck on the previously deployed stent during advancement before reaching the target stent. No further stenting was required. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the nc sprinter device was being used to post-dilate a new non-medtronic stent. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use an nc sprinter balloon catheter to treat a lesion in the ostium of the left main coronary artery. There were no abnormalities in relation to anatomy. The lesion was pre-dilated. The device passed through a previously-deployed stent. The device was being used to post-dilate the stent. It is reported that the balloon got stuck on the stent after the stent was deployed. The balloon was fully deflated prior to attempting to remove the device. The stent was then removed from the patient using the balloon. It was reported that no force was used to remove the balloon. No further intervention was required to remove the balloon or the stent from the patient. No damage was reported to the stent upon its removal. No patient injury was reported.
 
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Brand NameNC SPRINTER 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 Key7116339
MDR Text Key101185511
Report Number9612164-2017-01931
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P790017
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
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2020
Device Catalogue NumberNCSP4012X
Device Lot Number213125129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2017
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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