MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	131F7P
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include, kra , catheter, continuous flush, dyg, catheter, flow directed, dqe, catheter, oximeter, fiberoptic.A report is being submitted on this returned swan ganz catheter due to product evaluation findings.Report of ""would not inflate"" was confirmed.Balloon had leakage through a tear along the distal bond.The tear extended to about 1/2 of the circumference of the catheter tip.Balloon edges did not appear to match up at the tear.All through lumens were patent without any leakage or occlusion.No other visible damage from catheter.The device history record review was completed and the unit passed all manufacturing inspections without non-conformance related to the failure reported.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
As reported during use the swan ganz catheter was tested before a case and the balloon inflated.It inflated in the body as well but once it was removed the balloon had already deflated without the doctor doing so., they tried to inflate the balloon again outside the body and it would not inflate.There was no patient injury.The device is available for evaluation.
Additional Manufacturer Narrative
A supplemental report is being submitted due to the completion of the engineering evaluation that was initiated to assess for any manufacturing related processes which could be correlated to the reported lot numbers.It was confirmed that this nonconformance is related to a capa for balloon inflation and corrective actions will be implemented.As part of the manufacturing process, all balloons get inflated and deflated to assure a correct condition.Deflation time check of the balloon is performed.As part of the packaging process, 100% of the units after balloon bonding step passes through a balloon inspection.Additionally, qa sampling visual and functional inspections is performed.

• Brand Name: SWAN-GANZ
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 24015691
• Report Number: 2015691-2026-10281
• Device Sequence Number: 9136773
• Product Code: DQO
• UDI-Device Identifier: 00690103000412
• UDI-Public: (01)00690103000412(17)270421(11)250421(10)66529339
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• 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): 01/21/2026

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: 131F7P
• Device Lot Number: 66529339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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