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

Model Number 777F8

Device Problem 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 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product, a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that inaccurate cardiac index (ci) measurement was indicated during use.Indicated ci value varied between 0.8 l/min/m2 and 2.0 l/min/m2 over a short period of time.The expected value was 2.5 l/min/m2.The patient was not treated based on the incorrect value.The value was not affected by the patient condition.No error message was displayed.There was no occlusion, leakage or kink noted in the catheter.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and three three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 31.5 and 86 cm proximal from the catheter tip.No fault messages appeared on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.8 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for 5 minutes without error.The thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistency was observed on eeprom data.Resistance value of the thermal filament circuit was within specification, measuring 37.91 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.No other visible damage or inconsistency to the catheter body, balloon, or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of catheter issue could not be confirmed during the analysis.The catheter responded appropriately during functional testing.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have 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.

Manufacturer Narrative

The lot number was obtained and a device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES< PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8224729
• MDR Text Key: 132541433
• Report Number: 2015691-2019-00098
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61444619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1