MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ; SWAN GANZ THERMODILUTION CATHETER

Model Number	131F7
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
The device has been requested to be returned but has not yet arrived.When it arrives and the product evaluation has been completed, the results will be sent in a supplemental submission.The lot number is unknown; therefore, the device history record review cannot be completed.Additional product codes, kra, dyg, dqe.
Event or Problem Description
It was reported that there are inaccurate values that occurred during patient use with a swan ganz true size catheter.The values received and the values expected were not given by the facility.The cables and modules that were involved were exchanged for different equipment, but that did not solve the issue.Instead, the ev1000 flotrac was employed for hemodynamic monitoring.The facility reported that this occurred in the last several weeks, but was unable to give an exact date of occurrence.There was no inappropriate patient treatment administered.There was no patient harm or injury.
Additional Manufacturer Narrative
The device will not be returned for evaluation as the facility stated it is unavailable.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 if some procedural factors may have contributed to the event.As part of the catheter manufacturing process a 100% of the units go through an electrical inspection.The complaint affected unit was not returned for evaluation, therefore a product non-conformance or device failure could not be confirmed and a root cause could not be determined.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 this monthly review.

• Brand Name: SWAN GANZ
• Common Device Name: SWAN GANZ THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PUERTO RICO; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21865893
• Report Number: 2015691-2025-03018
• Device Sequence Number: 17323571
• Product Code: DQO
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 131F7
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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