MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774F75

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 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

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.No actions will be taken at this time.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 is well described in the literature.The duration of catheterization should be the minimum required by the patient¿s clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.With any hemodynamic monitoring, values can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.It is unknown whether user or procedural factors contributed to this 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 during use of a swan-ganz catheter, variations in cardiac output (co) values, unreliable svo2 values, and heart rate (hr) discrepancies were noticed on the hemosphere monitor.An error message "isq4" was reported to have been displayed.Additionally, the hemosphere oximetry cable reportedly overheated on a regular basis, even though the module was attached without touching anything.It was noted that the issues occurred on the same day and the catheter remained in the patient for 7 days.The issues occurred while the patient was asleep and did not make sense to the clinician based on the patient¿s stable condition.The displayed co values were not provided by the customer nor did the customer compare the values to any other source; however, the customer stated the ¿expected value was a normal cardiac output.¿ the unreliable svo2 readings were noted when compared to the hospital¿s co-oximeter (co-ox) via blood sample, so it was suggested to review the in-vivo calibration.Again, the unreliable values and the co-ox values were not provided by the customer and ¿the expected value was a normal svo2 reading¿.Lastly, the patient¿s heart rate (hr) was displaying at 20bmp, while on the drager monitor it was reading 80bpm.There was no patient injury due to the events and the patient was not treated based on the values in any of the reported instances.In order to solve the issue, tech support was called.It was determined that additional support and understanding of the technology is needed.Therefore, edwards personnel will be present during the next cases.The suspect swan-ganz catheter was discarded.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8190788
• MDR Text Key: 131507063
• Report Number: 2015691-2018-05523
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• 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