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	07/02/2024
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.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 the d205f7 swan-ganz pacing td catheter was unable to pace from the beginning of use after catheter insertion.The issue was resolved by replacing the catheter.The kind of surgery/examination the catheter was used for or whether the patient had cardiac conduction defect was unable to be obtained.There were no patient complications reported.
Additional Manufacturer Narrative
Our product evaluation lab received one d205f7 catheter with attached monoject 1.5 cc limited volume syringe, 1 three-way stopcock, 2 din adaptors and non-ew contamination shield which located on the catheter body at 30 cm to 95.5 cm proximal from tip.The customer report of pacing issue was confirmed.Continuity testing found that there were intermittent conditions in the ventricular proximal and atrial distal circuits, when flexing the electrode area of the catheter.The rest of the circuits were continuous without short conditions.No visible damage or inconsistency was observed from catheter body, syringe, connectors and balloon.All through lumens were patent without any leakage or occlusion.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 36.9 c when submerged into a 36.9 c water bath.Thermistor circuit was continuous and there were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.An engineering evaluation has been completed.The complaint for pacing difficulty was confirmed by objective evidence.However, based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.In-depth investigation is not required since the failure is not confirmed to be associated to a manufacturing/design defect.A corrective action will not be taken at this time.As part of the manufacturing process, 100% of the units go through an electrode electrical inspection.This condition is not related to a labeling nonconformance.Pra escalation triggers are not met.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19822878
• Report Number: 2015691-2024-05629
• Device Sequence Number: 8665653
• Product Code: LDF
• UDI-Device Identifier: 00690103197334
• UDI-Public: (01)00690103197334(17)251217(11)231218(10)65458869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 12/17/2025
• Device Model Number: D205F7
• Device Lot Number: 65458869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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