MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE SWAN-GANZ CCOMBO V; CATHETER, FLOW DIRECTED

Model Number	777F8
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: kra- catheter, continuous flush.Dqe- catheter, oximeter, fiberoptic.Dqo- catheter, intravascular, diagnostic.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.
Event or Problem Description
It was reported that during use of the swan-ganz catheter the temperature value was not consistent, it fluctuated between 30 c and 48 c and caused the co values to stop running.When the catheter had consistent pressure on the port it seemed to work, however when the catheter is moved the values became inconsistent and co values no longer appeared.Troubleshooting included using a new co cable and cco cable test.There was no patient injury.
Additional Manufacturer Narrative
The device was not 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.As part of the manufacturing process 100% of the units go through an electrical inspection.A device history record review was completed and documented that device met all specifications upon distribution.No corrective actions will be taken at this time.

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22391818
• Report Number: 2015691-2025-05411
• Device Sequence Number: 15735010
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: 00690103146554
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 777F8
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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