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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND 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 01/13/2017
Event Type  Injury  
Manufacturer Narrative
Post investigation of literature events - patient lesion morphology conclusion added fdc
=
50. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Date of event -date of publication endovascular treatment and morphology typing of chronic ostial occlusion of the subclavian artery doi: 10. 3892/etm. 2017. 4203. 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
This study reviews the treatment of the chronic obstructive lesions in the subclavian artery. Patient 7 : a 0. 014'' non medtronic wire was inserted into the lsca ostium via the femoral access. Repeated attempts to pass the wire through the occlusion with the support of a sprinter legend balloon catheter were unsuccessful. Another 0. 014-inch wire was then selected. An angiography following approximately 2-cm advancement of the wire revealed that the distal artery exhibited an antegrade flow; however, the wire tip was not in the lumen with the arterial dissection forming at the lesion. The procedure was immediately aborted.
 
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Brand NameSPRINTER RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7113384
MDR Text Key106863088
Report Number9612164-2017-01919
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
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2017
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 Received11/30/2017
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

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