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

Model Number TS105F5

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The reported lot number 6171980 was not a valid number; therefore, a review of the manufacturing records could not be completed.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether user or procedural factors contributed to the stated event.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.No corrective or preventative actions are required at this time.

Event Description

It was reported that during use of a 5f swan-ganz catheter, the physician was getting incorrect cardiac output (co) values using a non-edwards brand maclab monitor and cable.Examples of the values were initially reported as ¿right heart pressure readings of 12 and 6.¿ on follow-up with the customer, he was unsure if perhaps the clinician had hooked up the injectate to the wrong port; however, the values were ¿notably incorrect.¿ the customer did not provide the displayed values vs.The expected values but stated that the fick method was used to obtain the correct co numbers.Using the same equipment, they switched to a 7f swan, which worked and provided "good numbers." there was no patient injury.Patient demographics were requested and are unknown.Unfortunately, the suspect 5f swan-ganz catheter was discarded.

Manufacturer Narrative

The correct lot number associated to the product was obtained.A device history record review was completed and documented that the device met all specifications upon distribution.Udi #(b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 8457619
• MDR Text Key: 140536650
• Report Number: 2015691-2019-01051
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 61719880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1