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

Model Number	D97120F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One swan-ganz pacing catheter was received by our product evaluation laboratory for a full examination.The report of "pacing catheter did not work" was confirmed.Continuity testing confirmed a full open condition of both proximal and distal circuits.Cut down of the catheter body was performed to expose the pacing lead wires.Distal leadwire was found to be broken under the balloon.Proximal leadwire was found broken at 4cm from distal tip.No visible damage or abnormality was observed from catheter body or balloon.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min without leakage.Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results 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 part of this monthly review.
Event or Problem Description
As reported, during device preparation in a tavi procedure, the overpacing function of this swan-ganz pacing catheter did not work.The issue was solved by replacing the catheter.Patients demographics were unable to be obtained.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.A root cause could not be determined at this time.The affected final work order documentation and manufacturing were verified, and no deficiencies were found.As per manufacturing process, the units go through various inspections such as continuity test for the distal and proximal electrodes, for the wire insertion into the catheter tube and final continuity test.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21603500
• Report Number: 2015691-2025-01903
• Device Sequence Number: 13065454
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)260225(11)240226(10)65596834
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 02/25/2026
• Device Model Number: D97120F5
• Device Lot Number: 65596834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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