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

Model Number	131F7P
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One swan-ganz catheter was received for evaluation.The reported issue was confirmed.The recommend guidewire for distal lumen of this catheter model is 0.025" per the ifu.A lab sample 0.025" guidewire was inserted from tip to hub and stuck at 5 mm from the tip.The guidewire was then inserted from hub to tip and stuck at same area of the tip.Cut down was performed, unknown clear material was noticed attached to the inner lumen wall which narrowed the inner lumen.All other lumens were patent without any air leakage or occlusion.The balloon inflated clear, concentric and remained inflated for a period of time without leakage.No other visible damage was observed from catheter body.Ir spectrum of unknown material showed similar absorption characteristics when comparing to cycloheptane like material.Further investigation was performed at the manufacturing site.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.As part of the manufacturing process, a leak and flow test is performed to all of the units as per internal procedure.Also, all of the units go through a guidewire inspection from distal hub through the backform area.As per chemistry analysis of the unknown material found in the lumen, the ir spectrum of unknown material showed similar absorption characteristics when comparing to cicloheptane.This component was verified in the bill of material of the subassembly and is not part of the affected product.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 this monthly review.
Event or Problem Description
As reported, during use in patient, the guidewire did not pass through this swan-ganz catheter.There was no allegation of patient injury.The device was available for evaluation.As per engineering evaluation findings, contamination was found inside the fluid path.The material occluding the lumen showed a compositional match of 51.84% with cycloheptane.This component was verified against the bill of material (bom) for the corresponding subassembly and it was determined that this component is not part of the affected product.Patient demographics not provided.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state road 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23749906
• Report Number: 2015691-2025-09846
• Device Sequence Number: 5854475
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)250820(11)230821(10)65205033
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K233824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2025
• Device Model Number: 131F7P
• Device Lot Number: 65205033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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