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

Model Number 744F75

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 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that an abnormal pap (pulmonary artery pressure) values were observed on the first day of use of a swan ganz catheter.No further information could be obtained at this time.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 two three-way stopcocks was returned for evaluation.A non-edwards introducer with contamination shield was located on the catheter body between 30 cm and 94.5 cm proximal from the catheter tip.Clotted blood was observed from the catheter.Per edwards pressure monitoring ifu doc-(b)(4) rev.A, "poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively complaint pressure tubing, small bore tubing, loose connections, or leaks".No visible damage or inconsistency was observed from the catheter body, connectors, balloon or returned syringe.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.No fault messages appeared on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.9 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 39.28 ohms.Catheter passed in-vitro calibration on vigilance ii monitor.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.Customer report of pressure measurement issue could not be confirmed during analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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.All waveforms on pressure monitor are damped to some degree.It is important to have the appropriate amount of damping (filtering) in the system.Inadequate damping will result in excessive resonance in the system and an overestimate of systolic pressure.The opposite occurs with overdamping.In both cases the mean arterial pressure is the most accurate.An underdamped trace is often characterized by a high initial spike in the waveform.An overdamped trace shows as an obvious and significant reduction in the pressure tracing.Damped waveforms (over and under) may have several etiologies and nurses are well trained to trouble shoot when it occurs.Because it is so well recognized it is unlikely to result in an injury.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

The initial report submitted stated that the swan ganz catheter displayed abnormal pap (pulmonary artery pressure) values on the first day of use.Additional information was obtained and it was reported that a dampened waveform for pulmonary artery pressure (pap) was observed on the first day of use.The patient was not treated based on the abnormal value.An error message was not displayed.The value was not affected by the patient condition.The catheter was not exchanged.No other troubleshooting was performed.Information such as if the value and waveform matched or if there were any occlusion, leakage or kink noted in the catheter was unknown.Patient demographic information requested but unavailable.Given that a dampened waveform was observed, this is now a non-reportable event.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 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: 8680916
• MDR Text Key: 147953545
• Report Number: 2015691-2019-02079
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K924452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 61572113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1