MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ VIP; SWAN GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER

Model Number	831F75P
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was discarded at the facility and not available for product evaluation.The lot number was not provided; therefore, the device history record review could not be completed.An engineering evaluation has been initiated to assess for any manufacturing related processes that could be correlated to the complaint.Additional product codes, dqo, dqe, kra.
Event or Problem Description
It was reported that there was a failure with a swan ganz thermodilution catheter.The swan ganz catheter displayed a temperature that was different from the patients oral temperature.The oral temperature was 36.6c and the temperature provided by the catheter was 35.8c.There were no fault messages displayed.There was no inappropriate patient treatment administered.There was no allegation of patient injury.
Additional Manufacturer Narrative
The catheter was discarded and not returned 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 an electrical inspection process.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 VIP
• Common Device Name: SWAN GANZ THERMODILUTION VEINOUS FUSION PORT 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: 21295786
• Report Number: 2015691-2025-00698
• Device Sequence Number: 15390181
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: 00690103003031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 831F75P
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/27/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown