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

Model Number	096F6J
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded at the facility and not available for return.The lot number is unknown, therefore, the device history record review could not be completed.An engineering evaluation was completed.As part of the manufacturing process 100 percent of the units go through an electrical inspection process.Without the return of the product it is not possible to determine if some damage or defect existed that could have contributed to the event.There is not sufficient evidence to determine if this complaint was related to manufacturing, design, or labeling.It is not known if any 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 this monthly review.
Event or Problem Description
It was reported that there was balloon deflation difficulty with the swan ganz thermodilution catheter.Before the catheter was placed in the patient, the clinician tried to inflate then deflate the balloon.The balloon would not deflate.It is unclear whether the balloon syringe was removed from the gate valve.The device was discarded at the hospital, it is not available for return and product evaluation.There was no patient injury reported.

• Brand Name: SWAN GANZ TRUE SIZE
• Common Device Name: SWAN GANZ 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 20614768
• Report Number: 2015691-2024-08339
• Device Sequence Number: 8821133
• Product Code: DQO
• UDI-Device Identifier: 00690103000245
• UDI-Public: 00690103000245
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 096F6J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/05/2024
• 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