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 Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

It was reported that error messages for ¿check catheter¿ and ¿cable connection¿ were observed and it was unable to measure cco from the beginning of surgery.The monitor and the cable were checked but no problem was observed.The catheter was replaced and then the cco measurement was obtained properly.There were no patient complications reported.

Manufacturer Narrative

One catheter was returned for evaluation.An arrow contamination shield and introducer were also returned.The catheter body was received kinked at 45.5cm proximal of the catheter tip.The thermistor was submerged in a 37.0c water bath and read 37.0 c on vigilance ii monitor.The thermal filament circuit showed a full open condition during continuity testing.The thermistor circuit was continuous.There were no open or intermittent conditions.Visual examination was performed under microscope and found an area of the thermal filament cover to be torn over the filament traces.The damaged area was located 19.3cm proximal to the catheter tip and measured 0.075" x 0.065" in size.A dissection of the damaged area was performed to determine if the filament was damaged underneath.One trace was found to be damaged and it appeared that a portion was missing.The damage does not appear to be a heat related issue, but may be due to something hitting the thermal filament from outside the catheter.No visible inconsistencies were observed on eeprom data.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.Visual examinations were performed under microscope and with the unaided eyes.A device history record review was completed and documented that the device met all specifications upon distribution.The error message "check thermal filament connection" was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 3913218
• MDR Text Key: 4517059
• Report Number: 2015691-2014-01525
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2014

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: 06/02/2014
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 07/03/2014
• 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