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

Model Number	D97130F5
Medical Device Problem Code	No Pacing (3268)
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
The suspect swan ganz catheter was discarded and not available for return.The device history record review is pending.Once the results are available, they will be sent in a supplemental submission.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to this complaint.
Event or Problem Description
It was reported that there was a failure with a swan ganz bipolar pacing catheter.The clinician stated that it would not pace during use.They attempted to replace the monitor and the cable to resolve the issue.But the issue still continued.The procedure being performed was a transcatheter aortic valve replacement.There was no inappropriate patient treatment administered.There was no patient injury.
Additional Manufacturer Narrative
The device was discarded and was not returned.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.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 PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 21624862
• Report Number: 2015691-2025-01988
• Device Sequence Number: 20960007
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)260711(11)240711(10)65849686
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 07/11/2026
• Device Model Number: D97130F5
• Device Lot Number: 65849686
• Was Device Available for Evaluation?: No
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 77 KG