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	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the pacing catheter, it was unable to pace.The team tried new pacer boxes and replaced the cables however, the catheter still did not work.A new catheter worked as expected.There was no patient injury.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
One model d97130f5 pacing catheter with monoject limited volume syringe was returned for evaluation.The customer report of would not pace was confirmed.Short condition was observed between distal and proximal electrodes.Cut down was performed on the catheter.Proximal leadwire was looped at the catheter tip and was in contact with distal electrode.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage was observed from catheter.The device history record review was completed and no related non-conformances were found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.Therefore, a root cause could not be determined at this time.As part of the manufacturing process, 100% of the units undergo an electrical continuity test for the proximal and distal electrodes, a delamination inspection and the stripping process of the bifilar nickel magnet wire, and an electrode and tip inspection.The instructions for use also contains 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.

• 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): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23008277
• Report Number: 2015691-2025-07413
• Device Sequence Number: 21459913
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)261122(11)241122(10)66105292
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Device Lot Number: 66105292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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