MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

Model Number	X3820SJD
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested for return for a product evaluation.It has not arrived.Once the product evaluation has been completed a supplemental report will be submitted with the findings.The lot number is unknown.Therefore, the device history record review cannot be completed.Additional product codes, dre and dqe.Additional 510k number k110167.
Event or Problem Description
It was reported that there was a malfunction with the oximetry central venous catheter, during use.The catheter body became kinked near the distal end of the backform.As a result, the catecholamine medication was not infused continuously into the patient.The medication became stuck at the kinked portion of the catheter.There was no patient injury.
Additional Manufacturer Narrative
The device was discarded and not returned for product evaluation.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.As part of the manufacturing process 100 percent of the units go through a catheter flow inspection process.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Common Device Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 21096650
• Report Number: 2015691-2025-00122
• Device Sequence Number: 12955709
• Product Code: DXG
• UDI-Device Identifier: 00690103197587
• UDI-Public: (01)00690103197587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown