MAUDE Adverse Event Report: Edwards Lifesciences DR SWAN-GANZ VIP; CATHETER, FLOW DIRECTED

Model Number	831F75P
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): Edwards Lifesciences DR; parque industrial de itabo; haina, san cristobal ; DR
• Manufacturer (Section G): Edwards Lifesciences DR; parque industrial de itabo; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd,; irvine, CA 92618
• MDR Report Key: 50872949
• Report Number: 2015691-2026-18823
• Device Sequence Number: 15808854
• Product Code: DYG
• UDI-Device Identifier: 00690103218282
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 831F75P
• Device Lot Number: 67832696
• Was Device Available for Evaluation?: Yes
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown