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

Model Number 777F8

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that an unknown long, fine, fiber-like material came out from the lumen of a swan ganz catheter during de-airing before use.The catheter was exchanged and the problem was solved.It is unknown what in lumen the unknown material was found.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One swan ganz catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards contamination shield was located on the catheter body between the 70 cm and 100 cm marker.As received, a wire-like material, approximately 12 mm long, was attached to the proximal injectate hub with tape.No other visible damage or abnormality to the catheter body, balloon, or returned syringe was observed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.The wire-like material was sent to chemistry for testing.Visual examination was performed under microscope at 10x magnification.Customer report of contamination issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Manufacturer Narrative

The wire-like material was sent to chemistry for scanning electron microscopy/energy dispersive x-ray spectroscopy (sem/eds) testing.Results detected nickel and the ir spectrum of the unknown wire-like material showed similar absorption characteristics when compared to poly ethyl cyanoacrylate-like material.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is standard practice to inspect and flush the catheter before use.In this instance, there was material that came out of the catheter during catheter preparation.When there is material in the fluid path there is the potential for the material to embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.This incident occurred before use so there was no patient compromise noted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8039967
• MDR Text Key: 128255657
• Report Number: 2015691-2018-04537
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/15/2018

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: 05/23/2020
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61382238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 12/02/2018; 07/23/2020
• Supplement Dates FDA Received: 11/19/2018; 12/20/2018; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1