MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; SWAN-GANZ CATHETER

Model Number 834F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that during use in cardiac surgery patient of a swan ganz catheter, it was not possible to measure the temperature of the patient.The cable and the modules were replaced 3 times, however the issue persisted.Initially, the temperature reading was 34.9, then with each change of modules and cables, the temp changed to 36.2, 38, 35.6, 34.0, then disappeared altogether.The patient remained stable and there was no allegation of patient injury.Patient demographics were unable to be obtained.

Manufacturer Narrative

One 834f75 catheter with a 1.5cc syringe and a non-ew contamination shield were returned for examination.The reported event of temperature issue was confirmed.The catheter was connected to a vigilance ii monitor and check thermistor connection error message was shown.There was an intermittent condition in the thermistor circuit.A cut down was performed on the thermistor connector housing.The leadwire was wrapped around but not soldered to the rt pin.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The proximal injectate lumen was occluded with clotted blood and it was not able to remove with warm water or a guidewire.Dry blood residues were noted at port.The remaining lumens were patent without leakage or any sign of occlusion.No other visible damage was observed from the catheter body.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 are well described in the literature.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient's clinical manifestations.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.

Manufacturer Narrative

This serves as a correction to the previously reported product evaluation reported through report # 2015691-2021-01101 in which the condition was confirmed.Through further investigation, this issue was found to not be confirmed.Please see following updated product evaluation.Further investigation found the reported event of inaccurate temperature readings issue was not confirmed however, intermittent connection condition was confirmed.As received the catheter was connected to a vigilance ii monitor, no temperature readings were displayed and "check thermistor connection" error message was shown.There was an intermittent condition in the thermistor circuit.A cut down was performed on the thermistor connector housing, no visible inconsistencies were noticed.Continuity testing to the distal side of the thermistor circuit revealed an intermittent condition at the thermistor bead.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The proximal injectate lumen was occluded with clotted blood and it was not able to remove with warm water or a guidewire.The remaining lumens were patent without leakage or any sign of occlusion.No other visible damage was observed from the catheter body.A personnel acknowledgment was conducted to the manufacturing personnel about the "thermistor - intermittent condition at bead.".

• Brand Name: SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: 11267552
• MDR Text Key: 232859271
• Report Number: 2015691-2021-01101
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1