MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ; CATHETER, FLOW DIRECTED

Model Number	D97130F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Edwards lifesciences was unable to perform due diligence efforts to retrieve the suspect device for analysis as there was no customer contact information provided in the voluntary incident report.No product was returned for evaluation; therefore, a definitive root cause could not be determined, and corrective or preventive action is not indicated at this time.The lot number was not provided thus a device history record was not reviewed.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.
Event or Problem Description
Edwards lifesciences was notified via a direct voluntary incident report submission to the fda that a customer experienced, during either a hybrid or transcatheter aortic calve replacement in an elderly female patient, the pacing catheter malfunction and the wires were "removed intact." per the customer, the pacing wire may be internally severed.The cable is bent and looks to be broken internally.There was no allegation of patient injury.The voluntary incident report did not include customer contact information, patient information or product information related to the reported event.

• Brand Name: SWAN-GANZ
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco ; *
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21376553
• Report Number: 2015691-2025-00989
• Device Sequence Number: 12917737
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: 00690103150438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K822723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: D97130F5
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/13/2025
• 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: Female