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

Model Number	774F75
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dqo- catheter, intravascular, diagnostic dqe- catheter, oximeter, fiberoptic kra- catheter, continuous flush.The device will not be returned for evaluation.Without 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.The device history record review was performed and the product passed all manufacturing inspections without nonconformances.As part of the manufacturing process, 100% of the units go through a balloon inspection.The instructions for use (ifu) also contains the following warning: pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, do not inflate above the recommended volume.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
It was reported that during use of the swan-ganz catheter the balloon ruptured.The balloon was tested before insertion and was working properly.The swan was floated without any issues, the clinician used a 9f arrow introducer.When the clinician tried to deflate the balloon there was resistance and the blood was visible in inflation syringe.The swan was removed and they did not place a second swan.The balloon was not intact and only a small part of the balloon was visible.On echo, the anesthesia team reported seeing a small hyperechoic area near the pulmonic valve.The cabg procedure continued without any issues.The surgeon flushed the pulmonary veins, there were no issues.After the cabg procedure was completed, another echo was performed and the anesthesia team did not see the hyperechoic area near the pulmonic valve, and instead saw a hyperechoic area in the right ventricle.They could not conclude if this area was a small fragment of the balloon.The patients postop recovery and hemodynamics are normal.There was no patient injury.

• 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): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23437554
• Report Number: 2015691-2025-08976
• Device Sequence Number: 14636001
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)261025(11)241025(10)66022264
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: 774F75
• Device Lot Number: 66022264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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