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	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: kra, dqe, dqo a product evaluation was completed on the returned catheter.The reported event of balloon burst was confirmed.During visual inspection balloon was found ruptured at the central area.The balloon edges did not match at the ruptured region.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body.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/ design defect.As part of the manufacturing process, 100% of the manufactured units go through a balloon inflation process performed.A device history record review was completed and documented that device met all specifications upon distribution.In the preparation section of the instructions for use (ifu) it is stated that inflation is usually associated with a feeling of resistance.On release, the syringe plunger should usually spring back.If no resistance to inflation is encountered, it should be assumed that the balloon has ruptured.Discontinue inflation at once.The catheter may continue to be used for hemodynamic monitoring.However, be sure to take precautions to prevent infusion of air or liquid into the balloon lumen.The ifu provides instructions to 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.Lastly, the warnings section of the ifu states that 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 part of the monthly review.
Event or Problem Description
As reported, before use in the patient, the balloon of a swan-ganz catheter burst.There was no allegation of 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 00610 ; * 00610
• 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: 22948019
• Report Number: 2015691-2025-07203
• Device Sequence Number: 9125085
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)260624(11)240624(10)65795057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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 Expiration Date: 06/24/2026
• Device Model Number: 777F8
• Device Lot Number: 65795057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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