MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER; 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	05/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 part of this monthly review.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Patient demographics unable to be obtained.
Event or Problem Description
As reported, in patient with high-grade av block associated with syncope treated with isoproterenol and requiring temporary pacing, this swan ganz pacing catheter did not pace when it was connected to the external pacing box.The catheter had been inserted as per procedure and all output settings were appropriate.Multiple troubleshooting steps were undertaken, including checking connections, replacing the pacer box, flushing the line and confirming placement by multiple physicians without success.A new catheter of the same model was then inserted, which functioned normally.There was no allegation of patient injury; procedure was prolonged as multiple physicians attempted to troubleshoot malfunctioning wire.The device was available for evaluation.Patient demographics not available.
Additional Manufacturer Narrative
Added information to section d9 and h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of pacing difficulties was unable to be confirmed.No visible damage or abnormality was observed from catheter body, balloon or windings.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 min.Without leakage.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.As part of the manufacturing process the units go through an electrical inspection process.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• 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, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22148227
• Report Number: 2015691-2025-04441
• Device Sequence Number: 18095754
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233983
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 06/11/2026
• Device Model Number: D97120F5
• Device Lot Number: 65807127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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 Sex: Unknown