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)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported during use with a swan ganz catheter the proximal infusion lumen hub was found detached.This was after cardiac surgery in the icu.The detachment was not confirmed during surgery.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
Additional product codes include.Kra catheter, continuous flush.Dqe catheter, oximeter, fiberoptic.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 has not yet been 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.
Additional Manufacturer Narrative
One swan ganz catheter was returned for evaluation.Customer report of the proximal infusion lumen hub of this swan ganz catheter was found detached was confirmed.As received, extension tube of infusion lumen was broken off at distal end of infusion lumen hub.Cross surfaces of the broken catheter body appeared uneven and rough.Balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Pa distal and proximal injectate lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from balloon or returned syringe.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.

• 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: 22003544
• Report Number: 2015691-2025-03739
• Device Sequence Number: 15800346
• Product Code: DYG
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)260603(11)240603(10)65734136
• 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): 07/18/2025

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: 06/03/2026
• Device Model Number: 777F8
• Device Lot Number: 65734136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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