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	Low Blood Pressure/ Hypotension (1914)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during cardiac surgery (mitral valvuloplasty) for an adult patient, this oximetry catheter had large amount of blood leakage in addition to catecholamine and propofol leakage from the optical module connector.The patient's blood pressure dropped and vital signs became unstable due to this leakage.Vasopressor was administered and the patient was checked whether he contracted infection as additional treatment.No blood transfusion was required.The patient is a male and in his 60s.The extension tube of optical module connector was clamped with forceps to prevent the leakage since large amount of leakage was observed.The patient condition is recovered.The patient was transferred to a hospital ward from the icu, and there was no allegation that the patient was transported from the hospital ward afterward.The device will be available for evaluation.November 19th 2025 updated: the patient condition is recovered.The patient was transferred to a hospital ward from the icu, and there was no allegation that the patient was transported from the hospital ward afterward.
Additional Manufacturer Narrative
The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not been 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 Manufacturer Narrative
Customer report of leakage issue was confirmed.Blood was visible at optical module connector as received.Blood was removed during sample decontamination.Optic and kevlar fibers were removed from optic lumen for leakage testing of optic lumen.Interlumen leakage was observed between the distal and optical lumen.Interlumen leakage occurred in the catheter backform.No leakage or occlusion was observed in proximal 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 gap was observed inside the backform between distal lumen and optical fiber lumen that could lead to internal leakage.The device history record review was completed and the product passed without nonconformances.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: 23660494
• Report Number: 2015691-2025-09615
• Device Sequence Number: 4770236
• 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): 01/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: X3820SJD
• Device Lot Number: 66711195
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/29/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male