MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ; SWAN GANZ THERMODILUTION CATHETER

Model Number	131F7
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned, but has not yet arrived.When it arrives and the product evaluation has been completed, the results will be sent in a supplemental submission.The lot number is unknown, therefore, the device history record review cannot be completed.Additional product codes, kra, dyg, dqe.The other two report id numbers to link these events will be sent in a supplemental submission.
Event or Problem Description
It was reported that before use, that there was a hub disconnection on the swan ganz true size catheter.The blue tubing on the catheter became separated from the white port connector.The facility reported that this occurred three times in the last several weeks but was unable to give exact days of occurrence.There is no patient injury.
Additional Manufacturer Narrative
Submitting supplemental to send related report id numbers.
Additional Manufacturer Narrative
No product was returned for evaluation.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known is some procedural factors may have contributed to the event.An image was provided.Per the image evaluation, the detached hub can be confirmed however the product malfunction cannot be confirmed.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.As part of the manufacturing process, 100 percent of the units go through a leak test inspection.The ifu states, precaution.It is possible to stretch the body of the catheter and cause the thermistor's internal wires to detach, there by breaking the circuit.When testing and cleaning the catheter, do not forcefully wipe or stretch it.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 part of the monthly review.

• Brand Name: SWAN GANZ
• Common Device Name: SWAN GANZ THERMODILUTION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PUERTO RICO; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492019907
• MDR Report Key: 21866106
• Report Number: 2015691-2025-03021
• Device Sequence Number: 11939329
• Product Code: DQO
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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
• Device Model Number: 131F7
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 07/09/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/21/2025; 07/23/2025
• 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 Sex: Unknown