MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT; CATHETER, FLOW DIRECTED

Model Number	TS105F5
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ts105f5 catheter was returned for examination.The reported issue was unable to be confirmed.The thermistor connector was able to be connected to the lab 70cc2 cable without difficulty.The catheter was submerged in a 37.0 degrees c water bath and read 37.0 degrees c on the vigilance ii monitor.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.All through lumens were patent without any leakage or occlusion.Cut down was performed on thermistor connector and there was no visible abnormality.A device history record review was completed and documented that device met all specifications upon distribution.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.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 this monthly review.
Event or Problem Description
It was reported that this edwards 5fr swan-ganz was defective.The thermistor connector did not work.The event occurred when trying to calculate outputs.The customer tried switching out every cable and ultimately tried a second catheter.There was no injury to the patient.Medwatch 3902560000-2022-8054 was received with additional information that changed the reportability.It was reported that the swan was prepped and checked, and everything mechanically worked properly.Once inserted, the physician attempted to obtain thermodilutions.The numbers were very inaccurate and very extreme in both directions with no indication as to why.Patient demographics were provided.

• Brand Name: SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14951208
• Report Number: 2015691-2022-06660
• Device Sequence Number: 20180827
• Product Code: DYG
• UDI-Device Identifier: 00690103018295
• UDI-Public: (01)00690103018295(17)231216(11)211216(10)64113636
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K810124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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 Expiration Date: 12/16/2023
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 64113636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• 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: 06/28/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2021
• 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: 61 YR
• Patient Sex: Male