MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ TRUE SIZE; CATHETER, FLOW DIRECTED

Model Number TS105F5

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

The swan was prepped and checked, and everything mechanically worked properly.Once inserted into the body the physician's attempted to obtain thermodilution.The numbers were very inaccurate and very extreme in both directions with no indication of why it would be.It appears that the thermistor at the end of the swan was not reading the temperature correctly.

• Brand Name: SWAN-GANZ TRUE SIZE
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14842509
• MDR Text Key: 294859145
• Report Number: 14842509
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 64113636
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male