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

Model Number	096F6P
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned, but has not yet arrived.Once it has arrived and the product evaluation completed the findings will be submitted in a supplemental report.The lot number is unknown, therefore the device history record review could not be completed.
Event or Problem Description
It was reported that there was a malfunction with the swan ganz thermodilution true size catheter.The swan ganz catheter balloon would not deflate.There is limited information that was provided.During patient use.There is no patient injury.
Additional Manufacturer Narrative
The device was requested to be returned, but did not arrive for evaluation.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.As part of the manufacturing process 100 percent of the units go through a balloon inspection.The instructions for use ifu states to check balloon integrity by inflating it to the recommended volume.Check for major asymmetry and for leaks by submerging in sterile saline or water and deflate balloon before insertion.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 TRUE SIZE
• Common Device Name: TRUE SIZE THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492507706
• MDR Report Key: 21595006
• Report Number: 2015691-2025-01853
• Device Sequence Number: 15688145
• Product Code: DQO
• UDI-Device Identifier: 00690103000245
• UDI-Public: 00690103000245
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/18/2025

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: 096F6P
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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