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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 03/17/2017
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
It was reported that the physician intended to use a nc sprinter legend balloon catheter to treat a lesion in the mid lad following pci of the rca. The mid lad was reported to be severely calcified. It was attempted to dilate and treat the lesion with non-mdt balloons one of which burst. The physician then decided to use an nc sprinter balloon catheter which also burst. After several inflations, the winged balloon could not get to the mid lad. A new nc sprinter also could not cross. It was decided to stop the procedure however when removing the wires ,closure of the vessel was detected (timi 0) and was reported to be most likely due to dissection. This was treated by further (non-mdt ) ballooning leaving 70-80% residual stenosis with type b dissection. The patient was hemodynamically stable and free of chest pain.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key6546904
MDR Text Key74472662
Report Number9612164-2017-00560
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeID
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
Report Date 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/06/2017
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: 05/05/2017 Patient Sequence Number: 1
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