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

Model Number	D97120F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda premarket submission number: k822723.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.
Event or Problem Description
As reported, during a transcatheter aortic valve implantation, a swan-ganz pacing catheter could not pace.Distribution cables for the pacemaker were changed several times, but issue continued.There was no allegation of patient injury.
Additional Manufacturer Narrative
A product evaluation was completed on the returned catheter.The reported event of "could not pace" was confirmed.Continuity testing confirmed a full open condition of both proximal and distal circuits.Cut down of the catheter body was performed to expose the pacing lead wires.Both proximal and distal leadwires were found broken at 3.5cm from distal tip.Balloon latex appeared deteriorated and discolored.Multiple cracks and two tears; approximately 1mm, were evident on balloon latex.Balloon edges appeared to match at the tears.Leakage was observed through the tear on the balloon.Per procedure, latex deterioration is "a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.".No other visible damage was observed from catheter body or returned syringe.Both windings were intact.No visible damage or abnormality was observed from catheter body.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The device history record review was completed and the product passed without nonconformances.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.The affected final work order documentation and manufacturing were verified, and no deficiencies were found.100% of the units go through a delamination inspection of the bifilar nickel magnet wire, a continuity test is performed for the distal and proximal electrodes, and for the wire insertion into the catheter tube.A final continuity test is performed to the electrodes.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.

• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22548008
• Report Number: 2015691-2025-05882
• Device Sequence Number: 15572580
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)260530(11)240530(10)65800837
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Device Expiration Date: 05/30/2026
• Device Model Number: D97120F5
• Device Lot Number: 65800837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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