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)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after insertion of this bipolar pacing swan-ganz catheter, it did not sense.No further information was available.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product 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.
Additional Manufacturer Narrative
Finally, no product was received for evaluation.Patient demographics unable to be obtained.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 available information, and since no product sample nor objective evidence was provided for investigation, a definite root cause is unable to be determined.There are manufacturing controls to avoid potential causes related to the reported malfunction.
Additional Manufacturer Narrative
Updated section d9 (device availability) h6 (type of investigation), h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Finally, the product was received by our product evaluation laboratory for a full examination.The report of pacing issue could not be confirmed.As received, no visible damage or abnormality was observed from catheter body, balloon or windings.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 min.Without leakage.Based on further engineering evaluation, the report of pacing issue was unable to be confirmed since the unit was returned for evaluation, and no defect was found; therefore a product non-conformance or device failure could not be confirmed.

• 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: 20459424
• Report Number: 2015691-2024-07864
• Device Sequence Number: 7881143
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)250608(11)230609(10)65099263
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2025

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: 06/08/2025
• Device Model Number: D97120F5
• Device Lot Number: 65099263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 01/10/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/21/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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