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

Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded so there will be no product return and a product evaluation is unable to be completed.The model and lot number of the device are unknown so the device history record review is unable to be completed.Additional product codes, dqe, dqo.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to this complaint.
Event or Problem Description
It was reported before patient use with a pulmonary artery catheter, the introducer catheter tip cracked and all the continuously infusing medications leaked out.The patient became hemodynamically unstable.The information was provided through a voluntary medwatch.There was no patient injury.

• Brand Name: SWAN GANZ CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyn road; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES PUERTO RICO; state road indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon road; irvine, CA 92618 ; 9492017706
• MDR Report Key: 21995312
• Report Number: 2015691-2025-03698
• Device Sequence Number: 11840181
• Product Code: DYG
• UDI-Device Identifier: 00690103198430
• UDI-Public: (01)00690103198430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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
• Was Device Available for Evaluation?: No
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Unknown