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

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.

• Brand Name: SPRINTER RX
• Type of Device: CATHETERS, 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 Key: 7113384
• MDR Text Key: 106863088
• Report Number: 9612164-2017-01919
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• 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 Received: 12/13/2017
• 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 Received: 11/30/2017
• 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