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

Model Number	X3820SJD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported after surgery and returning from the icu during use in patient this oximetry catheter had medication leakage from the optical module connector.The issue was resolved by replacing the catheter.No further information including the name of leaked medication was available.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
Additional fda product codes include: dre dilator, vessel, for percutaneous catheterization.Dxg computer, diagnostic, pre-programmed, single-function.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review was not completed as no lot number was provided.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 Manufacturer Narrative
One oximetry catheter was returned for evaluation.Customer report of leakage issue was confirmed.Blood was visible at the optical module connector as received.Leakage was detected between the proximal lumen and optical fiber lumen inside backform.No leakage or occlusion was observed in distal and medial lumens.No other visible damage/inconsistency was observed from the returned catheter.A cut down of the backform was performed for further evaluation, and a crack of 4 mm was observed inside the backform between the proximal lumen and optical fiber lumen that could lead to internal leakage (see attached photo).The device history record review was not completed as a lot number was not provided.As part of the manufacturing process, 100% of the units go through a dry leak test.This dry leak test is performed after the backforming process and in the sub assembly manufacturing process as well.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.

• 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 LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23407847
• Report Number: 2015691-2025-08871
• Device Sequence Number: 13030804
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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?: Device Returned to Manufacturer
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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