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

Model Number	131F7P
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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 device preparation, the balloon of this swan-ganz catheter did not deflate.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Added information to section d9, h6 (type of investigation) updated section d3, g1 (manufacturing site for devices), h6 (component code), h6 (device code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of balloon did not deflate was unable to be confirmed during evaluation.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached which is within the limit of the maximum deflation time from full capacity.All through lumens were patent without any leakage or occlusion.No visible damage was observed on catheter or returned syringe.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.No product nor process malfunction could be identified since the reported condition could not be confirmed through the product evaluation.Based on further review by the engineers, it was verified that there are manufacturing controls to avoid potential causes related to the reported malfunction.Additionally, the ifu was reviewed and it states "passively deflate the balloon by removing the syringe and opening the gate valve".

• 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 PR ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal PR ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20810716
• Report Number: 2015691-2024-09049
• Device Sequence Number: 18455156
• Product Code: DYG
• UDI-Device Identifier: 00690103000412
• UDI-Public: (01)00690103000412(17)260517(11)240517(10)65763243
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 05/17/2026
• Device Model Number: 131F7P
• Device Lot Number: 65763243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG