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

Model Number 777F8

Device Problems Incorrect Measurement (1383); Defective Device (2588); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

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 during use of a swan ganz catheter, the continuous cardiac output (cco) measurement failed due to temperature fluctuations when using a vigilance ii monitor.It was confirmed that the issue was not related to the vigilance ii monitor.There was no allegation of patient injury or treated administered as a result of the temperature fluctuations.Patient demographics were requested and not provided.The lot number is unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 777f8 swan-ganz catheter with contamination shield and syringe.No fault messages showed up on the lab¿s vigilance 2 monitor when the catheter was connected.The thermistor was found to read 37.1°c when submerged into a 37.0°c water bath.The thermistor temperature reading was within specified accuracy, per the vigilance manual.The catheter ran continuous cardiac output (cco) in a 37.0°c water bath on the vigilance ii monitor for 5 timed minutes with no error.The thermistor and thermal filament circuits were continuous, with no open or intermittent conditions.No visible inconsistencies were observed on the eeprom data.The resistance value of the thermal filament circuit was measured at 36.88 ohms, which was in specification.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric, and remained inflated for more than 5 timed minutes without leakage.The catheter failed in-vitro calibration with the lab¿s cal-cup.Visible damage was observed on the tip of the optical fibers at the optical module connector.The bonding material was not present at the optical fiber tips, as per specification that calls for epoxy bonding at the optical fiber tip with the om connector.The optical module connector housing was opened and the fibers were examined.No light leakage was observed from the fibers in the coil area and catheter body.The customer complaint of "cco measurements failed" was not confirmed on evaluation.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.An unstable baseline temperature tracing can be an indication to the user to begin the troubleshooting process before a cardiac output measurement is attempted.The patient¿s body temperature can be obtained by different means and compared to the temperature obtained from the catheter.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort the attempt to obtain cardiac output.The catheter can be exchanged if desired.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 discovered through eeprom data on evaluation.A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP 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: 8238252
• MDR Text Key: 133084169
• Report Number: 2015691-2019-00142
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61374984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1