MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ PACING TD CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	D205F7
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.The device history review has not been completed as a serial/lot number was not provided.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that ventricular pacing was unable to be performed from the beginning of use after the catheter insertion.The d205f7 catheter was repositioned but the issue persisted.The issue was resolved by replacing the catheter.The following information was unable to be obtained what kind of surgery examination the catheter was used for or whether the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.
Additional Manufacturer Narrative
The d205f7 catheter was returned for evaluation.Customer report of pacing issue was confirmed.Continuity testing found that there was an open condition in the ventricular proximal circuit.The rest of the circuits were continuous without short conditions.Further examination found that there was a full open condition around ventricular proximal electrode in the ventricular proximal circuit.No visible damage or inconsistency was observed from catheter body, syringe, connectors and balloon.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.As part of the manufacturing process, 100% of the units go through an electrode electrical inspection.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.Therefore, no root cause could be established.The device history review was not completed as a lot number was not provided.The instructions for use provides the following warnings and precautions: this catheter requires special techniques for insertion and removal.Electrode dislodgement may result from pulling the catheter out through the percutaneous sheath.Avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.

• Brand Name: SWAN-GANZ PACING TD CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20340820
• Report Number: 2015691-2024-07484
• Device Sequence Number: 8023804
• Product Code: LDF
• UDI-Device Identifier: 00690103197334
• UDI-Public: 00690103197334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Model Number: D205F7
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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