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

Model Number	TS105F5
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of a ts105f5 it was unable to achieve a stable temp.The device was being used during a cardiac cath.The case was completed with a new catheter.There was no patient injury.Device is available for return.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
Our product evaluation lab received one model ts105f5 swan-ganz catheter.The customer report of inaccurate temperature was unable to be confirmed.No visible damage was observed from thermistor connector, catheter body, balloon.No error message was observed on hemosphere monitor.The thermistor was submerged in a 37.0 c water bath and read 37.1 c on hemosphere monitor.Thermistor temperature reading accuracy is +/-.3c per hemosphere manual.Thermistor circuit was continuous and there were no open or intermittent conditions.Thermistor connector was opened and no visible abnormalities were found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for more than 5 minutes without leakage.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the investigation, the complaint for inaccurate values was unable to be confirmed through product evaluation since the affected unit was returned for evaluation and no defect was found; therefore a product non-conformance or device failure could not be confirmed.As part of the catheter manufacturing process 100% of the units go through an electrical inspection.The complaint does not meet pra escalation triggers and a corrective action is not required at this time.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Common Device Name: CATHER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19484935
• Report Number: 2015691-2024-04394
• Device Sequence Number: 12770021
• Product Code: DYG
• UDI-Device Identifier: 00690103018295
• UDI-Public: (01)00690103018295(17)260304(11)240304(10)65623383
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 03/04/2026
• Device Model Number: TS105F5
• Device Lot Number: 65623383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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