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

Model Number	831F75P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The report of "material protruding from the catheter found close to the distal tip" was confirmed through the image provided by the customer.When the device arrived for evaluation, protruding material was not observed.However, approximately 4mm in length of the catheter body appeared to be missing at 2cm from distal tip.Damaged catheter body area appeared to be consistent with the protruding material shown in the customer picture.All through lumens were patent without any leakage or occlusion.No resistance was felt when water or air was injected into all through lumens.Balloon inflated clear, concentric, and remained inflated for 5 minutes without leakage.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.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, upon opening and inspection of this swan-ganz catheter, material protruding from the catheter was found close to the distal tip.There was no allegation of patient injury.The device was available for evaluation.As per evaluation results, approximately 4mm in length of the catheter body appeared to be missing at 2cm from the distal tip.Patient demographic data unable to be obtained.
Additional Manufacturer Narrative
Added: h2 (type of follow-up).Updated: g3 (date received by manufacturer), g6 (type of report), h6 (component code, investigation findings, investigation conclusions).The device was received for evaluation.The report of "material protruding from the catheter found close to the distal tip" was confirmed through the image provided by the customer.When the device arrived for evaluation, protruding material was not observed.However, approximately 4mm in length of the catheter body appeared to be missing at 2cm from distal tip.Damaged catheter body area appeared to be consistent with the protruding material shown in the customer picture.All through lumens were patent without any leakage or occlusion.No resistance was felt when water or air was injected into all through lumens.Balloon inflated clear, concentric, and remained inflated for 5 minutes without leakage.Further evaluation was performed by the engineers in the manufacturing site.There are manufacturing controls such as visual inspection after finishing the operations that use blades or scissors.The manufacturing procedure was reviewed, and there is no evidence to conclude that this condition could be related to the process, since there are established process controls to prevent the occurrence of the reported malfunction.Based on the available information, a definite root cause was unable to be determined.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21890438
• Report Number: 2015691-2025-03150
• Device Sequence Number: 15482693
• Product Code: DYG
• UDI-Device Identifier: 00690103218282
• UDI-Public: (01)00690103218282(17)260424(11)240424(10)65742852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 04/24/2026
• Device Model Number: 831F75P
• Device Lot Number: 65742852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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