MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH; PACING CATHETER

Model Number TOE135F75

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the distal lumen hub of the swan ganz catheter was detached during use.The issue was identified by the nurse after the patient returned to the icu.No blood leakage was observed from the detached hub.The catheter was removed without issue.Patient demographic information requested but not available.There were no patient complications reported.

Manufacturer Narrative

Patient demographic information was obtained as follows: patient sex is male, age 64.One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards three-way stopcock was attached at the pa distal hub.As received, extension tube of proximal injectate was completely detached from the backform.Distal lumen was patent without any leakage or occlusion.No other visible damage was found from the catheter body, balloon, or returned syringe.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.No error messages appeared on the lab vigilance ii monitor when the catheter was connected.Catheter passed in-vitro calibration on vigilance ii monitor.The thermistor was submerged in a 37.0 c water bath and read 37.0 c on vigilance ii monitor.The thermistor circuit was continuous and there were no open or intermittent conditions.The thermistor connector was opened and no visible abnormalities were found.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 detached component issue was confirmed, however, the distal lumen hub was not found to be detached during the analysis.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.In the event that an extension tube detaches from the backform, there is potential for an air embolism or blood loss, which could cause injury to the patient.The catheter should be clamped and exchanged if this issue occurs.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.

• Brand Name: SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco CA 00610
• MDR Report Key: 11859637
• MDR Text Key: 252337613
• Report Number: 2015691-2021-03054
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOE135F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR