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

Model Number	777F8
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2021
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.Edwards lifesciences was unable to perform due diligence efforts to retrieve the suspect device for analysis as there was no customer contact information provided in the voluntary incident report.No product was returned for evaluation; therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.A device history record review was completed and documented that device met all specifications upon distribution.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
Edwards lifesciences was notified via a direct voluntary incident report submission to the fda that a customer experienced, during use of the swan-ganz catheter, leakage through the white port.The patient had medication infusing through this port.The patient required a new catheter to be placed.There was no allegation of patient injury.The voluntary incident report did not include customer contact information, patient information or product information related to the reported event.

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco ; *
• 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: 21376560
• Report Number: 2015691-2025-00990
• Device Sequence Number: 15609451
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)230225(11)210225(10)63633241
• Combination Product (Y/N): N
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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 Expiration Date: 02/25/2023
• Device Model Number: 777F8
• Device Lot Number: 63633241
• Was Device Available for Evaluation?: No
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2021
• 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