MAUDE Adverse Event Report: Edwards LifeSciences PR SWAN-GANZ CCOMBO V; CATHETER, FLOW DIRECTED

Model Number	774F75
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, prior to patient use, the balloon of this swan-ganz catheter failed to inflate.There was no allegation of patient injury.
Additional Manufacturer Narrative
Additional product code: dqo, dqe, kra.A swan ganz catheter was returned for evaluation.The reported event of balloon leakage was confirmed.As received, balloon was completely torn around catheter body circumference at distal bonding area.Balloon edges at the torn area did not appear to match up.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A supplemental report will be forthcoming when the investigation is complete.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.Full udi: (b)(4).

• Brand Name: SWAN-GANZ CCOMBO V
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): Edwards LifeSciences PR; state rd indus pk 402 km 1.4; anasco 00610 ; PR 00610
• Manufacturer (Section G): Edwards Lifescience; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; +1(949)201-7706
• MDR Report Key: 50920933
• Report Number: 2015691-2026-18904
• Device Sequence Number: 12111145
• Product Code: DYG
• UDI-Device Identifier: 00690103146998
• 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: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Device Model Number: 774F75
• Device Lot Number: 67025459
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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