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 Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 34 cm and 83 cm proximal from the catheter tip.No introducer or packaging was returned.The distal side of the non-edwards contamination shield connector appeared detached and was not returned.As received, the catheter body at 13 cm proximal from the catheter tip was completely broken off.All lumens were exposed at the broken section.The thermistor leadwire and optical fiber with kevlar fiber were pulled out and also exposed from the broken section.Cross surfaces of the broken catheter body appeared uneven and rough.The distal and proximal uv bonding sites of the thermal filament were separated.The distal side of the thermal filament cover was slipped to proximal side.No missing components were found.Balloon inflation test was performed for the distal broken section only using a lab tuohy-borst connector.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.The distal lumen and balloon inflation lumen leaked from the broken section.The proximal injectate lumen was patent without any leakage or occlusion.No visible damage to the balloon or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air and a lab tuohy-borst connector.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.The customer report of catheter damage 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.

Event Description

It was reported that the catheter body got stuck with the introducer and it was difficult to remove the catheter during use.After removal, damage on the catheter was noted.There were no patient complications reported.Additionally, the size of the introducer was 8.5fr.

• 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 ; 9497564386
• MDR Report Key: 5740073
• MDR Text Key: 47895551
• Report Number: 2015691-2016-02007
• 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: 04/14/2016

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: 774HF75J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2016
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 06/21/2016
• 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