MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ; SWAN GANZ BIPOLAR PACING CATHETER

Model Number	D97120F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect swan ganz catheter has been requested to be returned for evaluation.It has not yet arrived.Once the product evaluation has been completed, the results will be submitted in a supplemental report.The device history record review is pending.Once the results are available, they will be submitted in a supplemental report.
Event or Problem Description
It was reported that during patient use there was a swan ganz bipolar pacing catheter that did not pace.The patient's heart rate was in the 20's and the pacing catheter would not capture.There was no patient injury.There was no inappropriate patient treatment reported.
Additional Manufacturer Narrative
The swan ganz catheter was returned for product evaluation.The reported issue that the device would not pace was confirmed.Continuity testing found that there was a full open condition in the distal circuit.The proximal circuit was found to be continuous.The catheter body was cut down to expose the pacing lead wires.The distal lead wire was broken at the solder area.An evaluation of the balloon found that when it was inflated it was clear and concentric with 1.3 cc of air.It remained inflated for five minutes without leakage.A visual inspection was performed and there was no damage to the balloon and the windings.Based on the available information, there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.It is not known if any procedural factors may have contributed to the event.As part of the manufacturing process 100 percent of the units go through an electrical inspection process.The instruction for use provides direction for preparation techniques and insertion procedure steps as a guideline and an aid for the physician.A precaution is given to avoid forceful wiping or stretching of the catheter during testing and cleaning so as not to break the electrode wire circuitry.Proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires.Care should be taken when handling the catheter.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.The device history record review was completed and all manufacturing inspections passed with no non conformances.

• Brand Name: SWAN GANZ
• Common Device Name: SWAN GANZ BIPOLAR PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20185632
• Report Number: 2015691-2024-06973
• Device Sequence Number: 18375469
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)250525(11)230526(10)65067756
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 05/25/2025
• Device Model Number: D97120F5
• Device Lot Number: 65067756
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: Female
• Patient Weight: 87 KG