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

Model Number	744F75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraoperative Cardiac Injury (4855)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use of the swan-ganz catheter, during a mitral valve replacement (mvr), the catheter was found to have perforated the right ventricle.After insertion of the catheter into the patient, it bent at a sharp angle in the right ventricle and reached the pulmonary artery.During mvr, the bent part of the catheter came into contact with the right ventricular wall, resulting in the perforation.This was discovered during chest closure as bleeding was observed.After checking, the catheter was found protruding from the apex of the heart, so a patch was applied to repair the damage.The surgery was completed without any further issues.No extension of the hospitalization period for treatment was required.Patient has since recovered.The device was discarded at the hospital.
Additional Manufacturer Narrative
Additional fda product codes include: dqe- catheter, oximeter, fiberoptic kra- catheter, continuous flush.Dqo- catheter, intravascular, diagnostic.The device was discarded by the facility.However, a supplemental report will be forthcoming when the engineering evaluation is 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
The device was not returned for product evaluation; however, an engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint of right ventricular wall perforation.Since a failure mode could not be confirmed further investigation could not be performed and a root cause could not be determined.However, as part of the manufacturing process a 100% of the units go through multiple inspection process performed from tip/balloons inspections processes.The instructions for use also contain the following warning: improper handling during catheter insertion may cause atrial or ventricular perforation and associated cardiac tamponade.As a precautionary measure, it is recommended to confirm the catheter placement with a chest x-ray immediately after insertion.

• Brand Name: SWAN-GANZ CCOMBO
• 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 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23492335
• Report Number: 2015691-2025-09114
• Device Sequence Number: 17339130
• Product Code: DYG
• UDI-Device Identifier: 00690103002850
• UDI-Public: 00690103002850
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 744F75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 46 KG