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

Model Number 777F8

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

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 the balloon inflation lumen.Balloon deflation time was 17.98 seconds which is out of specification.The specification for balloon deflation without a syringe attached is 4 seconds.During balloon deflation test, an unknown clear liquid came out from the balloon inflation lumen.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, balloon, or returned syringe was observed.The sample of the unknown clear liquid in the balloon inflation lumen was sent to chemistry for ir spectrum test.The ir spectrum showed similar absorption characteristics when comparing to water.Balloon test was performed using returned syringe.Visual examination was performed under microscope at 10x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon inflation and balloon deflation issues were confirmed.A device history record review was completed and documented that device met all specifications upon distribution.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¿s 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 it was difficult to inflate the balloon of the swan ganz catheter during balloon test before use.There was also difficulty deflating the balloon before use.It took time for balloon inflation and deflation.It is unknown if the inflation syringe was removed from the gate valve.Patient demographic information requested but unavailable.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 11375243
• MDR Text Key: 234887308
• Report Number: 2015691-2021-00270
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

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: 07/20/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63281667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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