MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY KIT; EDWARDS OXIMETRY CENTRAL

Model Number X3820SJD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

It was reported that the cannula needle punctured the artery when attempting to insert the x3820sjd oximetry catheter from right internal jugular vein during cardiac surgery.The patient was recovered after astriction without any blood transfusion.The oximetry catheter was no longer used and a swan ganz cco catheter was inserted from the left vein with a new puncture.The exact insertion site of cco catheter was unable to be confirmed.Procedural time for surgery and anesthesia took longer than expected due to astriction.Patient demographic information was requested but unavailable.The device was discarded at the hospital.There are no allegations of product malfunction.The device was discarded at the facility.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided, therefore a review of the manufacturing records could not be completed.The seldinger or modified seldinger technique is the standard insertion practice when accessing a vein for catheter insertion.It is recommended to use ultrasound to guide the needle for venous access which would mitigate the puncture of an artery.User technique is likely a factor in this event.The instructions for use (ifu) state "upon aspiration of venous blood, remove the needle and syringe." 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.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: EDWARDS OXIMETRY CENTRAL
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19140838
• MDR Text Key: 340561527
• Report Number: 2015691-2024-02999
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2024

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: Not provided
• Initial Date FDA Received: 04/18/2024
• 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): Required Intervention