MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ PACING TD CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	D205F7
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after catheter insertion in patient, a swan-ganz pacing thermodilution catheter did not pace.The issue was resolved by replacing the catheter.There was no allegation of 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
A product evaluation was completed on the returned catheter.The reported event of pacing issue was confirmed.Continuity testing found that there was an intermittent condition in the ventricular distal (#1) when flexing the electrode area of the catheter.The rest of the circuits were continuous without short conditions.No visible damage or inconsistency was observed from catheter body, syringe, connectors and balloon.All through lumens were patent without any leakage or occlusion.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 36.9 c water bath.Thermistor temperature reading accuracy is +/- 0.3c per hemosphere manual.Thermistor circuit was continuous and there were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.Based on the available information and previous evaluations, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.100% of the units go through an electrode soldering process.The instructions for use states 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 PACING TD CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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 ; 9492503939
• MDR Report Key: 21911282
• Report Number: 2015691-2025-03264
• Device Sequence Number: 15216725
• Product Code: LDF
• UDI-Device Identifier: 00690103197334
• UDI-Public: (01)00690103197334(17)251018(11)231019(10)65341657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/08/2025

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: 10/18/2025
• Device Model Number: D205F7
• Device Lot Number: 65341657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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