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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks with pressure tubes was returned for evaluation with original opened pouch and tray.No tyvek or introducer was returned.A kink with uv bonding partial separation was observed on the catheter body at 25 cm proximal from the catheter tip.Protrusion on the catheter body was observed at 61 cm proximal from the catheter tip.Stiff material was visible inside the catheter body between 25 cm and 61 cm proximal from the catheter tip.A lab sample of 0.021" guidewire (as recommended in the ifu) was inserted in the distal lumen from hub to tip and the guidewire stuck at 61 cm proximal from the tip.This guidewire was then inserted in the distal lumen from tip to hub and the guidewire stuck at 25 cm proximal from the tip.The areas were the guidewire became stuck matched the location of the kink and the protrusion on the catheter body.No other visible damage to the catheter body, balloon, or returned syringe was observed.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.No visible inconsistency was observed on eeprom data.Further examination of the catheter included placing the catheter on a bench and a stylet wire was used to push the wire like material out of the distal lumen.The od of the wire like material was measured at 0.023" and the length was 35.5cm.The material was sent to chemistry for energy dispersive x-ray spectroscopy (eds) testing.Results indicated the presence of the following elements in the wire like material; titanium and nickel.Further examination of the wire like material appeared to be wire used during the manufacturing process.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 eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of bent lumen issue was confirmed and in addition a wire like material was found inside the distal lumen during evaluation.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 thermistor lumen was bent before use.There were no patient complications 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 ; 9497564386
• MDR Report Key: 5926694
• MDR Text Key: 53909254
• Report Number: 2015691-2016-02661
• 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: 06/23/2016

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 Expiration Date: 06/15/2017
• Device Model Number: 774HF75J
• Device Lot Number: 60267979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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