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

Model Number 746F8

Device Problem Unable to Obtain Readings (1516)

Patient Problem Arrhythmia (1721)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

It was reported that the catheter was successfully calibrated, but upon insertion there were no waveforms detected (pa or cvp).The patient went into asystole twice and pa catheter insertion was aborted.The patient is in good condition at this time.

Manufacturer Narrative

We received one 746f8 catheter with an attached monoject 3ml syringe with 1.5 ml limited volume for examination.No pressure monitoring device was returned with the product.No fault messages showed up on the laboratory vigilance 2 monitor when the catheter was connected.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.The thermistor temperature reading accuracy is +/- 0.3c per the vigilance manual.The catheter ran cco in 37.0 c water bath on the vigilance ii monitor for 5 minutes with no error.The thermistor and thermal filament circuits were continuous, there were no open or intermittent conditions.No visible inconsistencies were observed on the eeprom data.Both the thermistor and thermal filament connectors were opened and found no visible inconsistencies.Resistance value of thermal filament circuit was measured and found to be within specification.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.In addition, there was no visible damage observed from the catheter body or returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETE
• Type of Device: CATHETER, FLOW DIRECTED
• 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 ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4838130
• MDR Text Key: 5941647
• Report Number: 2015691-2015-01355
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2017
• Device Model Number: 746F8
• Device Lot Number: 60012848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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
• Patient Outcome(s): Other