MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 746F8

Device Problems Incorrect Measurement (1383); Output Problem (3005)

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

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 are well described in the literature.With any hemodynamic monitoring, values can change quickly and dramatically and should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort further efforts to obtain readings and the catheter can be exchanged if desired.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.

Event Description

During follow-up by the edwards representative with the icu nurse on an issue, it was reported that a physician expressed some frustration and verbalized distrust with the swan-ganz catheters.The icu nurse explained that she has also heard other staff state that "the heart failure attendings¿ do not trust them¿, so she asked the physician what specifically makes her feel like she cannot trust them.The physician provided a specific patient example that occurred with a model 746f8 swan-ganz catheter in which the numbers did not make sense.The physician stated, ¿there is no scenario in which your svo2 would go down but your cardiac output would go up¿.She was concerned about the patient and went in and checked on him and said he looked ok, but she was concerned about treating off the unreliable numbers.She felt like this trend keeps happening.The icu nurse stated that she was aware the physician was also "worried about the svo2 reliability as well, because she has ordered additional passive draws on [my] patient in 25." the nurse stated that she tried to provide the thought that the technology more rapidly detects fluctuations, but the physician stated she "understood fluctuations, but that this was a bit unrealistic for the patient." there was no patient injury.No further details are known, including patient demographics.Electronic complaints for the hemosphere monitor, cable, swan-ganz module, and oximetry cable have also been opened for this event.

Manufacturer Narrative

It was originally reported that electronic complaints for the hemosphere monitor, cable, swan-ganz module, and oximetry cable had been opened for this event; however, there is no allegation that any of the electronic components contributed to this event.Therefore, no complaints were opened.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• 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: 9317522
• MDR Text Key: 194785246
• Report Number: 2015691-2019-04197
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• 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