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

Model Number	831F75P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, a swan ganz catheter had medication leakage where the white "proximal injectate" and blue tubing connect.Leakage occurred 6 days after insertion.No allegation of patient injuries.
Additional Manufacturer Narrative
Additional product codes: dqo, dqe, kra, dqk, drs, dsb, dxn, qaq.Additional premarket submission: k231248.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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.
Additional Manufacturer Narrative
A product investigation was completed on the returned catheter.The reported event of "leakage where the white proximal injectate and blue tubing connect" was confirmed.Visual examination found that proximal injectate extension tube was partially broken at the lumen hub.Cross surface of the broken extension tube appeared to be uneven and rough.All other through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No other visible damage was observed from catheter.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A root cause has not been determined at this time.A supplier notification was sent.

• Brand Name: SWAN-GANZ VIP
• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92614 ; 9492017706
• MDR Report Key: 22857256
• Report Number: 2015691-2025-06870
• Device Sequence Number: 12670515
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: 00690103003031
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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
• Device Model Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/18/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/31/2025
• 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