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

Model Number	774F75
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when testing prior to use in patient, the balloon of this swan-ganz catheter was damaged and did not inflate.Another catheter was used for the procedure.There was no allegation of patient injury.
Additional Manufacturer Narrative
A product evaluation was completed on the returned swan ganz catheter.Customer report of "balloon was damaged and did not inflate" was able to be confirmed.During visual inspection the balloon did not inflate due to leakage from a tear near the distal balloon bonding site.The tear size was approximately 2mm in length.The edges of tear did not appear to match up.All through the lumens were patent without any leakage or occlusion.No visible damage or abnormality was observed form catheter body syringe.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The reported issue was able to be confirmed through objective evidence from the product evaluation with the failure code 'balloon-tear, slit, cut- balloon.' based on the available information there is no evidence that supports or confirms the failure mode is associated with a manufacturing or design defect.A device history record review was completed and documented that device met all specifications upon distribution.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.G4: other product codes: dqo, dqe, kra.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: CATHETER FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km; anasco, puerto rico ; *
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon, rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22922297
• Report Number: 2015691-2025-07122
• Device Sequence Number: 13038341
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• UDI-Public: (01)00690103146998(17)260703(11)240703(10)65840163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: 07/03/2026
• Device Model Number: 774F75
• Device Lot Number: 65840163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown