MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 782F75M

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

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.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that the swan-ganz catheter was giving falsely low cardiac output readings.The swan was left in to perform the other hemodynamic readings until it no longer needed.No error message was observed.No patient complications were reported.Patient demographics were unable to be obtained.

Manufacturer Narrative

Patient demographics were added.

Manufacturer Narrative

One 782f75m with a non-edwards contamination shield was returned for examination.The reported event of co measurement issue was not confirmed.The catheter was submerged in a 37.0°c water bath and read 37.0°c on the vigilance ii monitor.The thermistor temperature reading accuracy is +/- 0.3°c per the vigilance ii manual.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.A cut down was performed on thermistor connector and there was no visible abnormality.The catheter body had one indentation at 80.7cm, aligned to the location of the proximal connector of the non-edwards contamination shield.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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 regard 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.It is unknown whether user or procedural factors contributed to the stated event.As part of the manufacturing process, 100% of the units go through an electrical inspection process.It should be noted that the ifu contain instructions to perform an electrical continuity test prior catheter insertion.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.Possible lot number 62744612 manufacturing date 10/16/2019 with an expiration date of 12/01/2021.

• Brand Name: SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10652406
• MDR Text Key: 210655149
• Report Number: 2015691-2020-13887
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K926450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

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: 12/01/2021
• Device Model Number: 782F75M
• Device Catalogue Number: 782F75M
• Device Lot Number: 62765300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 11/10/2020
• Supplement Dates FDA Received: 10/13/2020; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 105