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

Model Number 774F75

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

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.A device history records review was completed and documented that the device met all specifications upon distribution.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.For dpt, refer to medwatch #2015691-2017-04438.

Event Description

It was reported that during use of a swan ganz catheter with a disposable pressure transducer, continuous cardiac output was not able to be measured.In addition, pulmonary artery pressure values were inaccurate, higher than anticipated for the patient¿s clinical presentation.The swan ganz catheter and one of the three lumens of the dpt kit were replaced and the problem was solved.There was no error message displayed due to the inaccurate values.The patient was not treated based on the inaccurate measurements and there were no patient consequences relating to this issue.Patient demographics were not able to be obtained.

Manufacturer Narrative

Our product evaluation laboratory received one model 774f75 swan-ganz catheter with a monoject limited volume syringe and a non-edwards contamination shield.The proximal connector of the contamination shield was attached to the catheter at the 80cm mark.The pressure monitoring kit was not returned; however, the catheter body was found to be: a) kinked at 81.5cm proximal of the catheter tip and b) collapsed at 80.5cm proximal of the catheter tip.The location of the collapsed portion was aligned to the location of the proximal connector of the contamination shield.The thermistor was submerged in a 37.0°c water bath, as monitored by a temperature probe, and read 36.9°c on the vigilance ii monitor.The thermistor temperature reading was within specified accuracy.The catheter ran cco in a 37.0° c water bath on the vigilance ii monitor for 5 timed minutes without an error message.The thermistor and thermal filament circuits were continuous with no open or intermittent conditions.The eeprom data was found to be normal, both the stored data and the computed data matched.The resistance value of the thermal filament circuit was measured at 37.92 ohms, which was in specification.Using an optical module and vigilance ii monitor, the catheter passed in-vitro calibration with the lab cal-cup.With the returned syringe, the balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.All through lumens were patent without any leakage or occlusion.The report of "pulmonary artery pressure values was not well measured" was not able to be confirmed because the pressure monitoring kit was not returned.The report of "continuous cardiac output was not measured" was not confirmed, as the device responded appropriately during functional testing.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, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.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.No corrective or preventative actions are required at this time.(b)(4).

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7136691
• MDR Text Key: 96040622
• Report Number: 2015691-2017-04441
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 774F75
• Device Lot Number: 61013861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1