MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ; CATHETER, FLOW DIRECTED

Model Number	D97120F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a swan ganz catheter, lot 65515921, would not capture.Pacer box, cable, and red pins were replaced, but issue continued.Site had to replace the catheter to resolve the issue.There were no patient injuries and no delay.
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.
Additional Manufacturer Narrative
A product evaluation was completed on the returned (b)(4).The reported event of "had no capture" was confirmed.Continuity testing confirmed open conditions in both distal and proximal circuits.Cut down of the catheter body was performed to expose the pacing lead wires.Distal lead wire was found to be broken at the solder.Proximal lead wire was broken at 1cm from tip.Insulation was not present on the proximal lead wire at the location of damage.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.No visible damage was observed from the catheter or returned syringe.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Pacing difficulty was confirmed through product evaluation with the failure code "broken leadwire." as part of manufacturing, a final continuity test is performed to the electrodes during the final inspection.The affected final work order documentation and manufacturing were verified, and no deficiencies were found.In addition, a device history record review was completed and documented that 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 instructions for use states 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
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 19840020
• Report Number: 2015691-2024-05683
• Device Sequence Number: 17867478
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)260115(11)240116(10)65515921
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K822723
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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
• Device Expiration Date: 01/15/2026
• Device Model Number: D97120F5
• Device Lot Number: 65515921
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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