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

Model Number 777HF8J

Device Problems False Reading From Device Non-Compliance (1228); 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 04/11/2016

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 the cci value from the swan ganz catheter value read 12.0l/min/m2 when the expected value was from 3.0l/min/m2 to 4.0l/min/m2.Vig2 monitor was replaced but the problem was not solved.A flotrac system was used and correlated with the expected values.The patient was not treated based on the incorrect value.There was no occlusion, leakage or kink noted in the catheter.No further information was able to be obtained.There were no patient complications reported.

Manufacturer Narrative

One catheter with attached non-edwards syringe and 3 three-way stop cocks was returned for evaluation.A non-edwards introducer was located on the catheter body between 50 cm and 60 cm from the catheter tip.Cco measurement was evaluated and inaccurate value issue could not be confirmed due to a broken thermistor leadwire.As received, the thermistor lumen extension tube was stretched and rippled.Catheter was connected to vigilance ii monitor and "check thermistor connection" error message was shown and no blood temperature was shown.Continuity testing revealed that the thermistor circuit had a full open condition.Both the thermistor leadwires were found broken inside the thermistor lumen extension tube at 3.5 cm distal from the thermistor connector when the connector was cut opened.The thermal filament circuit was continuous, there was no open or intermittent conditions.No visible inconsistency was observed on eeprom data.Resistance value of the thermal filament circuit was within specification, measuring 39.26 ohms.The thermal filament connector was opened and no visible inconsistency was found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for 5minutes without leakage.Slight blood was observed from inside the attached introducer tube.No visible damage or inconsistency to the balloon was observed.Balloon inflation test was performed using lab syringe with 1.5 cc air as there was no volume marking on the returned syringe.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The customer report of cci measurement issue could not be confirmed during the evaluation.; however, the thermistor circuit was found to have a full open condition.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHI
• Type of Device: SWAN-GANZ CATHETER
• 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: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5637501
• MDR Text Key: 45315581
• Report Number: 2015691-2016-01510
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

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 Model Number: 777HF8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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