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

Model Number	096F6
Medical Device Problem Code	Failure to Deflate (4060)
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.Once it has arrived and the product evaluation has been completed a supplemental submission will be sent.The lot number is unknown; therefore, the device history record review cannot be completed.Additional product codes, dyg, dqe, kra.
Event or Problem Description
As reported, during set up, there was an issue with a swan ganz catheter balloon.During testing of the balloon it would not properly inflate.It was underinflated after testing and then it would not deflate.There was no patient harm or injury.
Additional Manufacturer Narrative
The device was requested to be returned, but did not arrive for product evaluation.Therefore, a root cause could not be determined.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the issue.As part of the manufacturing process 100 percent of the balloons go through a balloon inspection.Based on the available information, there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.It is not known if 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 part of the monthly review.

• Brand Name: SWAN GANZ TRUE SIZE
• Common Device Name: SWAN GANZ 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 ; 9492017706
• MDR Report Key: 21356399
• Report Number: 2015691-2025-00931
• Device Sequence Number: 21102064
• Product Code: DQO
• UDI-Device Identifier: 00690103000245
• UDI-Public: (01)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): 03/21/2025

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: 096F6
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/20/2025
• 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