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

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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.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.
Event or Problem Description
It was reported that during use of the oximetry catheter, after the patient had been transferred to the icu, the catheter was found to have saline, unknown medication and a small amount of blood leakage from the optical module connector.The unknown leaked medication was serous.During orthopedic surgery in the operation room, the patient went into cardiac arrest and this oximetry catheter was inserted to the patient along with extracorporeal membrane oxygenation (ecmo).The patient condition is under treatment.No catheter replacement was performed.No patient injury occurred and no additional treatment was required due to this leakage issue.
Additional Manufacturer Narrative
One oximetry catheter was returned for evaluation.The customer report of leakage issue was confirmed.There was a leakage from the optical module connector due to an interlumen leakage in the backform between distal lumen and optical lumen.A cut down of the backform was performed and a gap was observed inside the backform between distal and optical fiber lumen that could lead to interlumen leakage.Other through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body.The device history record review was completed and all manufacturing inspections passed with no non-conformances.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/design defect.As part of the manufacturing process 100% of the units go through a dry leak test.

• Brand Name: PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): BD APM; laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23294027
• Report Number: 2015691-2025-08338
• Device Sequence Number: 18648810
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• 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
• Device Lot Number: 66158825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG