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

Model Number	SWAN GANZ UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during placement of the swan-ganz catheter, when trying to float it, the catheter would get caught around the patient's automatic implantable cardioverter defibrillator (aicd).To replace the catheter the patient required an emergent trip to the cath lab.There was no allegation of patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: dqo- catheter, intravascular, diagnostic.Dqe- catheter, oximeter, fiberoptic.Kra- catheter, continuous flush.Dqk- computer, diagnostic, programmable.Drs- transducer, blood-pressure, extravascular.Dsb- plethysmograph, impedance.Dxn- system, measurement, blood-pressure, non-invasive.Qaq- adjunctive predictive cardiovascular indicator.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.No corrective actions will be taken at this time.The lot number was not provided thus a device history record was not reviewed.As a precaution, the instructions for use contain instructions on how to properly insert the catheter into the heart.

• Brand Name: SWAN GANZ UNKNOWN
• 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: john costa ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23619256
• Report Number: 2015691-2025-09472
• Device Sequence Number: 18400090
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: 00690103003031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: SWAN GANZ UNKNOWN
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• 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 Sex: Unknown