MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ; 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	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.
Event or Problem Description
It was reported that during use of this swan-ganz bipolar pacing catheter it was unable to pace.After catheter insertion, pacing was attempted but it did not work.The issue was resolved by replacing the catheter.Information including kind of surgery or examination the catheter was used for and if the patient had cardiac conduction defect was unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.
Additional Manufacturer Narrative
One d97120f5 catheter with monoject limited volume syringe was returned for evaluation.The reported issue of unable to pace was confirmed.Continuity testing found a short condition occurred between the proximal and distal circuits in the y-adaptor.There was no open or short condition observed in the leadwires between distal side of y-adaptor and the electrodes.There was no visible damage observed from catheter body, balloon, and windings.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Pacing difficulty during use was confirmed through the product evaluation.As part of the manufacturing process, 100 percent of the units go through an electrical continuity inspection process.Based on the available information, the complaint for pacing issue is potentially related to manufacturing defect, however, based on the investigation and the information available, a root cause could not be determined.A product risk assessment (pra) was generated for the short condition at the y-adaptor between proximal and distal lead wires for the bipolar pacing catheters.A device history record review was completed and documented that device met all specifications upon distribution.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.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jon diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20078805
• Report Number: 2015691-2024-06645
• Device Sequence Number: 7699348
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)250111(11)230112(10)64780009
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 01/11/2025
• Device Model Number: D97120F5
• Device Lot Number: 64780009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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