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

Model Number	D97130F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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, just right after insertion in the patient, a swan-ganz pacing catheter did not pace.When this catheter was replaced, the problem was solved.There was no allegation of patient injury.
Additional Manufacturer Narrative
A product evaluation was completed on the returned bipolar pacing catheter.The reported event of pacing issue was confirmed.Continuity testing confirmed a full open condition of the proximal circuit and distal circuit.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.It was observed that the proximal and distal leadwire were broken.The insulation of proximal leadwire was missing until 3.5 cm from tip of leadwire.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for more than 5 min.Without leakage.No visible damage or defect was observed from the balloon, windings, catheter body and returned syringe.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A device history record review was completed and documented that device met all specifications upon distribution.Based on the available information and previous evaluations, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.100% of the units the units go through a delamination inspection of the bifilar nickel magnet wire, a continuity test is performed for the distal and proximal electrodes, and for the wire insertion into the catheter tube.A final continuity test is performed to the electrodes.The instructions for use states provides the following warnings and precautions: this catheter requires special techniques for insertion and removal.Electrode dislodgement may result from pulling the catheter out through the percutaneous sheath.Avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21709537
• Report Number: 2015691-2025-02310
• Device Sequence Number: 14616417
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)251213(11)231214(10)65445669
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K822723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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 Expiration Date: 12/13/2025
• Device Model Number: D97130F5
• Device Lot Number: 65445669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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