MAUDE Adverse Event Report: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO; SWAN-GANZ CATHETER

Model Number T173F6

Device Problems Output above Specifications (1432); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 0.8 cc limited volume syringe and an attached non-edwards three-way stopcock at the proximal injectate hub was returned for evaluation.No visible damage or abnormality to the catheter body, balloon or returned syringe was observed.No error message was observed on the vigilance ii monitor.The thermistor was submerged in a 37.0 c water bath and read 36.8 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.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using returned syringe with 0.8 cc air by holding the balloon under water for 5 minutes.Visual examinations were performed under microscope at 10x magnification and unaided eye.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of co measurement issue could not be confirmed during the analysis.The catheter responded appropriately during functional testing.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 as the complaint was not confirmed by product evaluation.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 value of cardiac output (co) was higher than expected during use of this swan ganz catheter.Both the expected and indicated values could not be obtained.The catheter was exchanged and the problem was solved.The patient was not treated based on the incorrect value.There was no occlusion, leakage or kink noted in the catheter.The value was not affected by the patient condition.It is unknown if an error message was displayed or not.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO
• Type of Device: SWAN-GANZ CATHETER
• MDR Report Key: 8531966
• MDR Text Key: 142757999
• Report Number: 2015691-2019-01383
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K915726
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: T173F6
• Device Catalogue Number: T173F6
• Device Lot Number: 61878285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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