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	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation and the device history record was not reviewed.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.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 product codes: kra, dqe, dqo.
Event or Problem Description
It was reported that vasopresser medication backed up to the vip port of a swan ganz catheter into the swandom and onto the bedsheets, after patient was transferred to icu.It was determined that the catheter was curled in the rv and needed to be replaced.A kink at the thermal coil was noticed after removal of catheter.The clinician assumed that the kink occluded the vip lumen which prevented the pressers from passing through.Catheter was checked prior to insertion and no defects were found.It was noted that anesthesia had difficulty placing the catheter in the or and took the team several attempts to successfully place it.Catheter was replaced successfully and there was no patient harm.

• 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 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21446919
• Report Number: 2015691-2025-01267
• Device Sequence Number: 12592814
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: 00690103146554
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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
• Device Model Number: 777F8
• 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: 02/10/2025
• Initial Report FDA Received Date: 02/24/2025
• 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