MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING PROBE AND CATHETERS; 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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a tavi procedure, this swan-ganz pacing catheter (manufacturer reference number (b)(4)) was correctly placed in the right ventricle, however, it was impossible to generate an electrical signal to stimulate the heart.As troubleshooting, different connections were tried without success.The device was replace with another one but the same issue occurred (manufacturer reference number (b)(4)).A third catheter without balloon was used successfully.As per customer's opinion, this was a manufacturing defect.There was no allegation of patient injury.The devices were available for evaluation.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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.
Additional Manufacturer Narrative
Updated section d9 (device availability) h6 (type of investigation), h6 (component code), h6 (investigation findings), h6(investigations conclusions) and h10 (related report numbers).The product was received by our product evaluation laboratory for a full examination.The report of pacing difficulties was confirmed.Continuity testing confirmed a full open condition of proximal circuit.Cut down of the catheter body was performed to expose the pacing lead wires.Proximal leadwire was found to be broken under the balloon.Distal circuit was continuous.No visible damage or abnormality was observed from catheter body or balloon.The balloon inflated clear and concentric with 1.3 cc air and 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.Based on further engineering evaluation, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.As part of the device manufacturing process, the units go through a inspection.

• Brand Name: SWAN-GANZ PACING PROBE AND CATHETERS
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21536642
• Report Number: 2015691-2025-01548
• Device Sequence Number: 12673285
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)260225(11)240226(10)65596834
• 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): 05/05/2025

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: 02/25/2026
• Device Model Number: D97120F5
• Device Lot Number: 65596834
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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 Age: 80 YR
• Patient Sex: Unknown