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

Model Number	774F75
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, a swan ganz catheter had deflation difficulties.Balloon was tested prior to insertion without issue.Balloon was successfully floated however there was no passive deflation when instructed to deflate.Syringe was exchanged for a different syringe, but there was still no deflation and resistance was felt.Swan was kept in the patient who was then transferred to intensive care unit.There was no patient injuries.Further information is unavailable.
Additional Manufacturer Narrative
Additional product code: dqo, dqe, kra.This device is not available for return.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A device history record review was completed and no related non-conformances were found.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.Full udi: (b)(4).

• 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 00610 ; PR 00610
• Manufacturer (Section G): Edwards Lifescience; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; +1(949)201-7706
• MDR Report Key: 50920846
• Report Number: 2015691-2026-18903
• Device Sequence Number: 5776647
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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): 09/28/2026

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
• Device Lot Number: 66412144
• Was Device Available for Evaluation?: No
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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