Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Investigation of recent device experience reports has made vascular solutions inc. (vsi) aware of a potential problem with the twin-pass(5200) twin-pass rx (5210) and twin-pass .023" (5230) dual access catheters. vascular solutions has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of embolism to the patient.