MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 131F7J

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One swan ganz catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage; however, resistance was felt when air was injected into balloon inflation lumen.An unknown clear yellowish liquid was observed inside the balloon.It was not able to fully deflate the balloon with syringe detached.Unknown clear liquid came out from balloon inflation lumen during deflating the balloon.The unknown material was removed and sent to chemistry for analysis.Per ifu, using the syringe provided, inflate the balloon with co2 or air to the maximum recommended volume.Do not use liquid.All through lumens were patent without any leakage or occlusion.No visible damage was observed from catheter body, balloon and returned syringe.No visible damage to the catheter body, balloon and returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5cc air.Visual examination was performed under microscope at 10x magnification.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon deflation issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Event Description

It was reported that the balloon of the swan ganz catheter did not deflate at the balloon test prior to use.It is unknown if the syringe was removed from the gate valve when the issue was observed.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Chemistry analysis indicated that the ir spectrum of the clear yellowish liquid in the balloon is consistent with that of water.In addition, the ir spectrum of the clear liquid in gate valve is also consistent with that of water.

Manufacturer Narrative

Water is used as part of the electrical inspection; however, water is not in direct contact with the catheter itself.Current manufacturing processes were verified, and no deficiencies related to the nonconformance were found.Per the ifu, "using the syringe provided, inflate the balloon with co2 or air to the maximum recommended volume.Do not use liquid.".

• Brand Name: SWAN-GANZ 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: 12062981
• MDR Text Key: 258733063
• Report Number: 2015691-2021-03765
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: 131F7J
• Device Lot Number: 63211187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Patient Sequence Number: 1