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

Model Number	114F7P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient demographics unable to be obtained.One swan-ganz catheter was received for a full examination.The report of balloon leakage was confirmed.As received, the balloon did not inflate due to a tear of approximately 2 mm in length near to distal balloon bonding site.The edges of balloon latex did not appear to match up.On the other hand, all through lumens were patent without any leakage or occlusion and no visible damage or abnormality was observed from catheter body or 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.A root cause was unable to be determined.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.As part of the manufacturing process all the units go through balloon and bonding inspection process.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, before use in patient, the balloon of this swan-ganz catheter leaked.There was no allegation of patient injury.The device was received for evaluation and the balloon was ruptured near to distal bonding site, the edges of balloon latex did not appear to match up.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22334441
• Report Number: 2015691-2025-05184
• Device Sequence Number: 9126567
• Product Code: DYG
• UDI-Device Identifier: 00690103000313
• UDI-Public: (01)00690103000313(17)260516(11)240516(10)65746801
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 05/16/2026
• Device Model Number: 114F7P
• Device Lot Number: 65746801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• 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: 06/05/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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