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

Model Number	D97120F5
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	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional premarket submission number: k822723.Device was discarded by the hospital.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.The lot number was not provided thus a device history record was not reviewed.No corrective actions will be taken at this time.
Event or Problem Description
It was reported that, during use, the electrodes of a swan ganz pacing catheter got stuck in a 3rd party sheath.Patient with a right intrajugular temporary wire in place came to the electrophysiology lab for a device placement.After the pacemaker procedure was completed, temporary wire was pulled under fluoroscopy.After unlocking the valve of the sheath, the wire was being pulled while leaving the sheath in place.As the temporary wire was close to exiting the sheath, resistance was felt and prompted the staff to pull slightly harder.This caused the electrodes to break off.To prevent it from migrating into the patient's circulatory system, staff grabbed a 10cc syringe and pulled the blood back into the side port then immediately pulled the sheath to remove it from the patient.While pressure was placed on the intrajugular site, the circulating nurse began inspecting the sheath.The nurse cut the sheath open and was able to find the electrode portion of the wire adhered to the locking portion of the sheath.However, the nurse was not able to remove it as it was stuck.The physician also visually inspected it and confirmed that nothing was left inside the patient.

• Brand Name: SWAN-GANZ
• 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: 22746640
• Report Number: 2015691-2025-06437
• Device Sequence Number: 9122376
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: 00690103150421
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K233983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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 Model Number: D97120F5
• Was Device Available for Evaluation?: No
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/08/2025
• 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
• Patient Sex: Unknown