MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V; SWAN-GANZ CCOMBO V THERMODILUTION CATHETER

Model Number	777F8
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include: kra, catheter, continuous flush.Additional product codes include: dqe, catheter, oximeter, fiberoptic.Additional product codes include: dqo, catheter, intravascular, diagnostic.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review is not yet completed.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
As reported before use in a patient the balloon of this swan ganz catheter detached when the catheter was advanced into the contamination shield of the teleflex 9f introducer.The fragments of the balloon remained in the inner tube of the contamination shield.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
One swan ganz catheter was returned for evaluation.Customer report of balloon issue was confirmed.As received, balloon was found to be ruptured at central area.Balloon edges did not match at the ruptured region.Contamination shield and missing balloon ruptured fragment were not returned.All through lumens were patent without any leakage or occlusion.No other visible damage was found from the catheter body.A device history record review was completed and documented that device met all specifications upon distribution.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 or design defect.Therefore a root cause could not be established.As part of the manufacturing process, 100% of the units go through a balloon inflation and visual inspection performed.This is to verify the integrity of the tip/inflation lumen of the catheter and the balloon.In the preparation section of the instructions for use ifu it is stated that inflation is usually associated with a feeling of resistance.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.The ifu provides instructions to check balloon integrity by inflating it to the recommended volume.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.

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: SWAN-GANZ CCOMBO V THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22128077
• Report Number: 2015691-2025-04366
• Device Sequence Number: 20925652
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)260626(11)240626(10)65795061
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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 Expiration Date: 06/26/2026
• Device Model Number: 777F8
• Device Lot Number: 65795061
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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