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

Model Number TS105F5

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303746868
• Report Number: 2015691-2022-06660
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103018295
• UDI-Public: (01)00690103018295(17)231216(11)211216(10)64113636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male