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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 UNK-CV-GWY-NCSPR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
An unknown medtronic 6-french judkins right guide catheter was used to demonstrate 100% right coronary stenosis with thrombolysis in myocardial infraction. An nc sprinter legend (pli 10) was used, which easily crossed the lesion. The balloon was inflated to 22 atm but a waist remained within the stenosis and a distal dissection developed. Non-mdt stenting was performed and overlapped with the deployment of a driver bms(pli 20) stent at 18 atmospheres. The waist remained unchanged. A second nc sprinter (pli30) was then used to post-dilate the lesion. At 25 atm, the balloon ruptured. Non-mdt rotational atherectomy was then performed and the lesion was finally successfully post-dilated using a third nc sprinter balloon (pli 40) which caused the waist to relax. The patient was discharged several days later.
 
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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 Key6783925
MDR Text Key82338944
Report Number9612164-2017-01080
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-GWY-NCSPR
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 Received07/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/10/2017 Patient Sequence Number: 1
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