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

Model Number	123F6P
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during testing this swan ganz catheter, the balloon did not deflate since the valve was not releasing.The issue was solved replacing the catheter.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Patient demographics unable to be obtained.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.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.
Additional Manufacturer Narrative
Added information to section d9, h6 (type of investigation) updated section h6 (component code).H6 (impact code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of deflation issue was unable to be confirmed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.The ifu indicates "passively deflate the balloon by removing the syringe from the gate valve".Balloon deflation time was within specification.Distal lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.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.The complaint affected unit was returned for evaluation and no defect was found.Therefore, a product non-conformance or device failure associated to manufacturing or design could not be confirmed.As part of the manufacturing process the manufactured units go through a balloon inflation process.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21932687
• Report Number: 2015691-2025-03381
• Device Sequence Number: 8907473
• Product Code: DYG
• UDI-Device Identifier: 00690103000375
• UDI-Public: (01)00690103000375(17)260426(11)240426(10)65623951
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2025

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: 04/26/2026
• Device Model Number: 123F6P
• Device Lot Number: 65623951
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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