MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR EDWARDS OXIMETRY CENTRAL VENOUS CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number	X3820SJD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.Additional fda premarket submission: k110167.
Event or Problem Description
As reported, during use in patient, the optical fiber of this oximetry cable was exposed from the catheter tip as the patient removed the catheter by themselves at icu.The catheter was inserted into the patient during cardiac surgery.The customer tried to check if there was any residuals in the patient's body with echo, but they were unable to identify if it was from the catheter or plaque.The patient is being monitored at icu without another oximetry catheter being inserted.There was no allegation of patient injury.
Additional Manufacturer Narrative
A product evaluation was completed on the returned triple lumen oximetry catheter.The reported event of optical fiber of this oximetry cable was exposed from the catheter tip was confirmed.As received into lab, both optic fibers were exposed from catheter tip.Adhesive was visible around the fiber bond site at catheter tip.Edges of exposed fibers showed smooth surface.Optical module connector was opened for further evaluation, and fibers inside optical connector were coiled and no visible inconsistency was observed inside optical module connector.No other visible damage/inconsistency was observed from the returned catheter.All thru-lumens were found to be patent and did not leak.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.As part of the manufacturing process, a 100% of the units go through a tip inspection.During this process, the tip area is inspected for adhesive and contamination, fiber or tip deformation, alignment between distal lumen and fibers, and exposed fibers.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21714638
• Report Number: 2015691-2025-02330
• Device Sequence Number: 21317580
• Product Code: DQE
• UDI-Device Identifier: 00690103197433
• UDI-Public: 00690103197433
• 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,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown