MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number	PE074F5
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.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 a part of the monthly review.
Event or Problem Description
It was reported that the pe074f5 pacing catheter pin connectors should have been labeled as distal and proximal respectively but both were found incorrectly labeled as proximal during use.The customer noticed this malfunction when the customer tried to reposition the catheter after connecting the pin connectors to an external pacemaker in the icu after catheter insertion.It is unknown if the pacing catheter paced or not.The patient suffered from heart failure and the catheter was used for impella operation in the icu.It was unknown if the patient had a cardiac conduction defect.When the device was replaced the problem was solved.There were no patient complications reported.The patient is a 69 year old male.
Additional Manufacturer Narrative
One pe074f5 swan ganz bipolar pacing was returned for evaluation.Customer report of pin connectors should have been labeled as distal and proximal respectively, but both were found incorrectly labeled as proximal was confirmed.As received, the labels on both of the pin connectors were proximal.No visible damage was observed from the catheter body, balloon, windings and returned syringe.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 minutes without leakage.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The device history record review could not be completed since the lot number is unknown.As part of the manufacturing process, 100% of the units go through a visual inspection as per procedures ensamblajes de bipolar pacing catheter assembly, and final inspection for electrode and tip.This inspection includes to verify the identification in each pin plug.Japanese ifu indicates instructions to handle the catheter with caution for proper functioning of the pacing catheter.However, there is no indications to verify for pins identification.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint and a capa has been generated to perform an investigation and corrective preventive actions for this issue.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Common Device Name: PACING CATHETER
• 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: 21104909
• Report Number: 2015691-2025-00153
• Device Sequence Number: 12779315
• Product Code: LDF
• UDI-Device Identifier: 00690103150438
• UDI-Public: 00690103150438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K813521
• 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): 03/18/2025

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 Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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 Age: 69 YR
• Patient Sex: Male