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

Model Number X3820SJD

Device Problem Difficult to Insert (1316)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

It was reported that resistance was felt and the x3820sjd oximetry catheter could not be inserted into the vessel from right internal jugular vein during use.The physician felt that the catheter tip would not advance further than the subcutaneous tissue.The dilator was reinserted 3 times, but the issue persisted.X-ray film confirmed that the guidewire was positioned correctly.As a troubleshooting, the catheter was replaced with a non-edwards terumo central venous catheter.During this catheter replacement, a new incision was required to dilate the insertion site for terumo catheter.After inserting the new catheter, blood leakage was observed from the insertion site since outer diameter of edwards and terumo catheters were different.The amount of blood leakage was unknown.It was likely that no blood transfusion was required.The patient was an adult.The device was discarded at the hospital.

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.

Manufacturer Narrative

A supplemental mdr is being submitted due to the change in reportability.Section h2 and h10 have been updated.It initially was reported that resistance was felt and the x3820sjd oximetry catheter could not be inserted into the vessel from right internal jugular vein during use.The physician felt that the catheter tip would not advance further than the subcutaneous tissue.The dilator was reinserted 3 times, but the issue persisted.X-ray film confirmed that the guidewire was positioned correctly.As a troubleshooting method, the catheter was replaced with a non-edwards terumo central venous catheter.During this catheter replacement, a new incision site was assumed to be required to dilate the insertion site for terumo catheter.When a new insertion site is required there may be risks in the placement of a central line such as pneumothorax and bleeding.The risk is greater when the central vein is accessed.Therefore, if the insertion difficulty results in the need for a new insertion site the potential for injury is not remote.However it was further clarified that a new insertion site was not required and that the original incision site continued to be used but was widened to accommodate a different catheter.It was determined that difficulty inserting an introducer, dilator or central venous catheter directly into the subcutaneous tissue is generally related to patient anatomy and/or user technique.When this occurs, it is a routine to trouble shoot.This may require exchanging the device over a guide wire; if this is able to be done on the same insertion site there is minimal risk to the patient.Therefore this is not a reportable event.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: PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT
• 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 ; 9492507258
• MDR Report Key: 17362403
• MDR Text Key: 320242323
• Report Number: 2015691-2023-14695
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/02/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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