MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ; SWAN-GANZ BIPOLAR PACING CATHETER

Model Number	D97130F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned for evaluation as it was discarded by the facility.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the events.It is not known if some procedural factors may have contributed to the events.The device history record review was completed and all manufacturing inspections passed with no non conformances.The instructions for use (ifu) provides the following warnings and precautions: this catheter requires special techniques for insertion and removal.Electrode dislodgement may result from pulling the catheter out through the percutaneous sheath.Avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.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
It was reported during use that this swan ganz pacing catheter would not capture.The remington disposable cables and medtronic pacer box was changed but this did not resolve the issue.There was no harm to the patient.The device is not available for evaluation as it was discarded by the hospital.

• Brand Name: SWAN-GANZ
• Common Device Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21540085
• Report Number: 2015691-2025-01564
• Device Sequence Number: 20755098
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)260711(11)240711(10)65849686
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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 Expiration Date: 07/11/2026
• Device Model Number: D97130F5
• Device Lot Number: 65849686
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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