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

Model Number 774HF75J

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem Arrhythmia (1721)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and 2 three-way stop cocks were returned for evaluation.A non-edwards contamination shield was located on the catheter body between 62.5 cm and 102 cm proximal from the catheter tip.No packaging or introducer were returned.The balloon inflated but failed to maintain its inflation due to leakage from a tear, approximately 0.5 mm long, around the central area of the balloon latex.All through lumens were patent without any leakage or occlusion.No visible damage to the catheter body or returned syringe was observed.No error message was found on the vigilance ii monitor when the catheter was connected to the monitor.The thermistor was found to read 37.0 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 specifications measuring 38.84 ohms.Both the thermistor and thermal filament connectors were opened and no visible inconsistencies were found.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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of balloon leakage issue was confirmed.However, the balloon deflation issue could not be confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that before use, the balloon of the swan ganz catheter was tested and functioned properly.As the catheter was floated, premature ventricular contractions (pvcs) were noted.The catheter was withdrawn into the right atrium and the pvcs stopped.At that time it was noted that the balloon would not deflate.After the catheter was removed, the balloon was checked and leakage was observed.(there was no information given as to how the catheter was removed from the patient.) the catheter was replaced and the problem was solved.No patient complications were reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5196457
• MDR Text Key: 30207984
• Report Number: 2015691-2015-02940
• 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: Other
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774HF75J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/02/2015
• 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