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)
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 swan-ganz pacing catheter was unable to pace from the beginning of use after insertion.No pacing waveform or spike were displayed.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
Our product evaluation lab received one d205f7 catheter with attached monoject 1.5 cc limited volume syringe, 2 three-way stopcocks and non-ew contamination shield which located tip on the catheter body between 66 cm and 113 cm proximal from tip.The customer report of pacing issue was confirmed.Continuity testing confirmed ventricle distal and ventricle proximal electrode with short conditions.No visible blood at thermistor connector.Leakage was observed from proximal side of 1 electrode when air was injected into thermistor/electrode lumen.An adhesive separation was observed from 1 ventricular distal electrode.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from catheter body, balloon and returned syringe.A device history record review was completed and documented that the device met all specifications upon distribution.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.The affected work order documentation was verified, and no deficiencies were found.As part of the manufacturing process, 100% of the units go through and leak and flow test in where a leak will be detected.The 100% of the units had been inspected for the dry leak and has been documented properly.Additionally, electrodes are inspected 100 % as well.As part of an additional assessment, the product evaluation cut the catheter between the electrodes 1 and 2 to verify the integrity of the leadwire.It was confirmed that there was no damage on the leadwires between these electrodes that were provoking the short condition.

• 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 CA 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: 20315593
• Report Number: 2015691-2024-07427
• Device Sequence Number: 7903189
• Product Code: LDF
• UDI-Device Identifier: 00690103197334
• UDI-Public: (01)00690103197334(17)251120(11)231121(10)65432473
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 11/20/2025
• Device Model Number: D205F7
• Device Lot Number: 65432473
• Was Device Available for Evaluation?: Yes
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown