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

Medical Device Problem Codes	Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for product evaluation, however, it has not arrived.Once it arrives and the evaluation completed a supplemental report will be submitted with the findings.The device history record review is unable to be completed as the model and lot number of the catheter is unknown.Additional product codes, dqe, dqo.
Event or Problem Description
It was reported that during use with a swan ganz catheter, the clinician had trouble obtaining accurate readings.Upon inspection of the swan ganz catheter there was a crack found in the blue proximal tubing that was attached to the monitor.It was noted that fluid leaked from the catheter when attempting to obtain cardiac output values.There was no patient harm or injury.
Additional Manufacturer Narrative
No product was returned for evaluation.Without the 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 is some procedural factors may have contributed to the event.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.No root cause could be identified since no product sample nor objective evidence was provided for investigation.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.

• Brand Name: SWAN GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon road; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES PUERTO RICO; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon road; irvine, CA 92618 ; 9492017706
• MDR Report Key: 21995319
• Report Number: 2015691-2025-03700
• Device Sequence Number: 14530884
• Product Code: DYG
• UDI-Device Identifier: 00690103198430
• UDI-Public: (01)00690103198430
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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 Age: 57 YR
• Patient Sex: Unknown