It was reported that indwelling location of this oximetry catheter slipped down into the mediastinum while changing the patients position on the first day of use.The catheter was inserted from the left internal jugular vein.At this facility, the catheters are occasionally inserted from the left internal jugular vein for bigger patients.There are no allegations of product malfunction against the edwards catheter.The device was discarded at the facility.Follow up was performed and requested but no additional information was provided by the facility.Risks of central venous catheter insertion in the internal jugular vein are well documented in the literature.Mechanical injuries are rare with about a 1 percent chance.These may include, but not limited to, vascular (0.8 percent chance of bleeding), cardiac, pulmonary (0.2 percent chance of pneumothorax) and placement complications with number of failed attempts accepted as a predictor of complication.Ultrasound guidance may reduce the risk of central venous catheter insertion complications and is recommended.It is recommended in the instructions for use (ifu) to confirm catheter placement, including continuous pressure monitoring, with fluoroscopy (if desired) and a chest x-ray after insertion.Additionally, the ifu includes warnings related to potential complications including vessel perforation, pneumothorax and hemomediastinum amongst others.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.
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