MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY KIT; CATHETER, OXIMETER, FIBER-OPTIC

Model Number X3820SJD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation of Vessels (2135)

Event Date 04/08/2024

Event Type  Injury  

Event Description

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.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19216419
• MDR Text Key: 341457864
• Report Number: 2015691-2024-03246
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other