MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR SWAN-GANZ VIP; CATHETER, FLOW DIRECTED

Model Number	096F6P
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dqo- catheter, intravascular, diagnostic.Dqe- catheter, oximeter, fiberoptic.Kra- catheter, continuous flush.No product was returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The instructions for use (ifu) cautions the user that inaccurate cardiac output measurements may be caused by incorrect placement or position of the catheter and excessive variations in pulmonary artery blood temperature.Some examples that cause blood temperature variations include but are not limited to: status post cardiopulmonary bypass surgery, centrally administered cooled or warmed solutions of blood products, and use of sequential compression devices.The device history record review was performed and the product passed all manufacturing inspections without nonconformances associated to the reported malfunction.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 the monthly review.
Event or Problem Description
It was reported that, during use, this swan ganz catheter provided inaccurate cardiac output readings.The patient received medication management, additional testing (echocardiogram), and extubation was delayed as a result of the inaccurate values.No patient injury was reported.The device is not available for return as it was discarded by the facility.

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21520846
• Report Number: 2015691-2025-01492
• Device Sequence Number: 20946020
• Product Code: DYG
• UDI-Device Identifier: 00690103000245
• UDI-Public: (01)00690103000245(17)261007(11)241007(10)65984747
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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: 096F6P
• Device Lot Number: 65984747, 65954177
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: Other; Hospitalization
• Patient Sex: Unknown