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.Blood was observed on the catheter body.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.Balloon deflation time was approximately 17 seconds, which is out of specification.The specification for balloon deflation without a syringe attached is 4 seconds.During balloon deflation test, an unknown yellow liquid was observed inside the balloon.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 to the catheter body or returned syringe was observed.The sample of the unknown liquid was sent to chemistry for analysis.The ir spectrum of the unknown liquid inside the balloon showed similar absorption characteristics when compared to water.Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of balloon deflation issue 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.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.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Patient parameters should correlate with the patient clinical manifestations.In this case it is unknown whether any user or procedural factors may have contributed to the stated event.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.

Event Description

It was reported that the balloon could not be deflated during use.The issue was observed when the wedge pressure measurement was about to switch to pa pressure measurement during cardiac diagnostic catheterization.As per the distributor, no additional access to the vascular system to remove the catheter was required, and the balloon was deflated in the end.Initially, it was unknown if the syringe was removed from the gate valve to deflate the balloon.However, additional information was received that the syringe was not removed from the gate valve when the issue was observed.The customer commented that balloon inflation and deflation did not perform as usual.The diagnostic catheterization was completed with no other issues.Patient demographic information request d but unavailable.There were no patient complications reported.

Manufacturer Narrative

Patient demographic information was obtained.Patient sex is female, age 83, weight 42 kilograms, with a history of atrial fibrillation and kidney failure.

• 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: 11732308
• MDR Text Key: 248835887
• Report Number: 2015691-2021-02691
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2021
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 42