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

Model Number	774F75
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	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, a swan-ganz catheter had a blood leakage from the optical module connector.There was no allegation of patient injury.Further information is not available.
Additional Manufacturer Narrative
Additional product codes: dqo, dqe, and kra.A product evaluation was completed on the returned catheter.The reported event of leakage issue was confirmed.As received, catheter body was cut at the tip.Mating part of catheter was not returned.Optical module was opened and blood residues were found inside.Optic and kevlar fibers were removed from optic lumen for leakage testing of optic lumen.Interlumen leakage was observed between the inflation and optical lumen.Interlumen leakage occurred in the catheter backform.Through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the issue.A supplemental report will be submitted once the evaluation is complete.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.
Additional Manufacturer Narrative
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 modes are associated to a manufacturing/design defect.As part of the manufacturing process, 100% of the units go through a leak and flow test 3 times in the sub assembly manufacturing process.The lot number was not provided thus a device history record was not reviewed.

• Brand Name: SWAN-GANZ CCOMBO V
• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22856042
• Report Number: 2015691-2025-06861
• Device Sequence Number: 15546968
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: 00690103146998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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 Model Number: 774F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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