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 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product(s), it is not possible to determine if damages or defects exist on the product(s), nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number(s) were 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

It was reported that the hospital has been having ongoing issues with cardiac output drift.The physician stated that lately this has been a frequent occurrence where the numbers do not make sense and ¿there is no scenario in which your svo2 would go down but your cardiac output would go up¿ and was concerned about treating off unreliable numbers.The physician stated this has been a trending occurrence and the icu nurse reported that they are frequently seeing the cardiac output values "drift all the way up to 10 on patients.The physician group and the staff are becoming more and more frustrated with the hemisphere equipment." there was no allegation of any patient injury.No patient demographics are known, as the specific dates of occurrence and specific details for each event are unknown.The specific lot numbers and affected quantities were also not provided.There is no known product available for return.

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: 9317478
• MDR Text Key: 194610027
• Report Number: 2015691-2019-04195
• 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
• 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