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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and a non-edwards plug was returned for evaluation.No packaging or introducer was returned.Clear material was found partially occluded in the distal lumen port at the catheter tip.No trail of the clear material was observed.The clear material was attached to the catheter and did not detach during evaluation.The balloon inflated clear and remained inflated for 5 minutes without leakage.The proximal injectate and infusion lumens were patent without any leakage or occlusion.No other visible damage to the catheter body, balloon, or returned syringe was observed.Further examination confirmed a partial occlusion in the distal lumen at the catheter tip.The substance was yellowish and soft but could not be collected for chemistry testing due to the small sample size.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.Customer report of inability to flush the lumen was not confirmed, however, occlusion trace was confirmed.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 lumen became unable to flush during use.It is unknown which lumen was involved.There were no patient complications reported.

• 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 ; 9497564386
• MDR Report Key: 6052346
• MDR Text Key: 58246417
• Report Number: 2015691-2016-03146
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2016

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: 777HF8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/24/2016
• 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