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

Model Number	777F8
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include kra catheter, continuous flush dqe catheter, oximeter, fiberoptic dqo catheter, intravascular, diagnostic.A report is being submitted due to the findings of this returned swan ganz catheter.Report of balloon wouldn't inflate was confirmed.Balloon had leakage through a 0.06 inch long tear at the distal end of the proximal balloon bond.However, the balloon latex did not appear to match at the tear.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from catheter body.The device history record review was performed and no manufacturing non conformances were identified associated to the reported malfunction.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.This condition is under investigation and final conclusions will be determined.There are manufacturing controls to avoid potential causes related to the "balloon tears" malfunction as follows: quality visual inspection, manufacturing visual inspection as part of the packaging process, 100% of the units after balloon bonding step passes through a balloon inspection, balloons get inflated and deflated to assure the condition of it and a leak and flow test is performed, and deflation time check of the balloon is performed.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 a part of the monthly review.
Event or Problem Description
As reported before use the swan ganz catheter balloon wouldn't inflate when they were checking at pre insertion.There was no patient injury.The device is available for evaluation.

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22971841
• Report Number: 2015691-2025-07271
• Device Sequence Number: 13075957
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)261021(11)241021(10)66095398
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K040287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: 777F8
• Device Lot Number: 66095398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2025
• 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: 08/12/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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