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

Model Number	777F8
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.Additional product codes: kra - catheter, continuous flush.Dqe - catheter, oximeter, fiberoptic.Dqo - catheter, intravascular, diagnostic.
Event or Problem Description
It was reported that before use of this swan-ganz catheter, it was found that the balloon was missing.The latex part was only around the tip of the catheter.When it was tried to inflate there was no balloon.There was no patient injury.
Additional Manufacturer Narrative
One 777f8 with monoject limitied volume syringe and non-edwards contamination shield was returned for evaluation.The reported issue of there was no balloon was not confirmed.The balloon latex was present at the tip, however, the balloon had leakage through a.07 long tear near the proximal bond and a.05 long tear near the distal balloon bond.The balloon latex did not appear to match at the distal tear.Crazing was also observed on the balloon.All through lumens were patent without any leakage or occlusion.There was no other visible damage was observed from catheter.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As part of the packaging process, 100% of the manufactured units passes through a balloon inspection.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.A corrective and preventive actions (capa) was generated to further investigate this issue.Notification to capa owner was performed.A device history record review was completed and documented that device met all specifications upon distribution.Per the ifu of the swan-ganz continuous cardiac output thermodilution catheters it states, check balloon integrity by inflating it to the recommended volume.Check for major asymmetry and for leaks by submerging in sterile saline or water.Deflate balloon before insertion.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 the monthly review.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92614 ; 9492017706
• MDR Report Key: 22922319
• Report Number: 2015691-2025-07123
• Device Sequence Number: 9116486
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)270107(11)250107(10)66211331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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 Model Number: 777F8
• Device Lot Number: 66211331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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