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
Event or Problem Description
It was reported that appropriate pacing waveform was not displayed on an electrocardiogram ecg using a d205f7 swan ganz pacing catheter and it was unable to pace during use.The issue was not resolved by repositioning the catheter.The following information was unavailable the phase when the catheter was unable to pace what kind of surgery examination the catheter was used for whether the patient had cardiac conduction defect or whether the catheter was replaced.Patient demographic information was requested but unavailable.There were no patient complications reported.
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.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.
Additional Manufacturer Narrative
The d205f7 pacing catheter was returned for evaluation.The customer report of a pacing issue was not able to be confirmed during evaluation.Continuity testing was performed on the distal and proximal ventricular circuits and the distal, central and proximal atrial circuits.There were no open, intermittent, or short conditions observed.As received, back form was cut at the junction between back form and catheter body.The length of cut was approximately 2 mm.No other visible damage or abnormality was observed from catheter body and returned syringe.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is +/-.3c per hemosphere manual.Thermistor circuit was continuous and there were no open or intermittent conditions.All through lumens were patent without any leakage or occlusion.Based on the documentation, there is no evidence that indicates that the manufacturing procedures were not followed by the manufacturing personnel.As part of the manufacturing process, 100% of the units go through a leak and flow test as per procedure.However, after performing the backend forming process the unit is verified for flash, and it is removed with blades.Therefore, this failure could be potentially related to manufacturing.A device history record review was completed and documented that the device met all specifications upon distribution.

• 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: 19982509
• Report Number: 2015691-2024-06106
• Device Sequence Number: 16834296
• 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
• 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): 10/29/2024

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: 08/14/2024
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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