MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD; PACING CATHETER

Model Number D205F7

Device Problem 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 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that the swan ganz was unable to measure co during use in the operating room.No error message was displayed on the nihon kohden monitor.The catheter was continued to be placed.After leaving the operating room, co measurement was restarted with a different nihon kohden monitor and the ci values varied between 3 to 7.The customer assessed that the indicated values were not far from the expected values, but considered the values to be unreliable since there was more variation than expected.Again, no error message was shown on the monitor.Blood temperature readings were stable at around 35.5 degrees c.No problem with catheter position was found.The customer did not mention resistance at the bolus injection.The patient was not treated based on the incorrect value.No occlusion or leakage was noted in the catheter.It is unknown if the value was affected by the patient condition.Inspection of both nihon kohden monitors was performed and no problem was found.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

A communication from the facility was received that the device will not be returned as covid-19 is impacting the return of the complaint unit.Without the return of the product, it is not possible to determine if damages or defects existed on the product.No further actions will be taken.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.

Manufacturer Narrative

Initial report stated that the device would not be returned as covid-19 was impacting the return of the complaint unit.However, the swan-ganz pacing thermodilution (td) catheter with non-edwards introducer and contamination shield was now returned for evaluation.The catheter was submerged in a 36.9c water bath and read 36.9c on vigilance ii monitor.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.Cut down was performed on the thermistor connector and no visible abnormality was observed.However, the catheter body had indentations at 33, 33.5, 104 and 105.5 cm from the catheter tip.The locations of the indentations were aligned to the locations of the distal and proximal adaptor of the returned contamination shield.Balloon inflation test was performed using lab syringe.Visual examination was performed under microscope 10 to 45x and with the unaided eyes.Customer report of cco measurement issue could not be confirmed 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.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10063494
• MDR Text Key: 194999864
• Report Number: 2015691-2020-11878
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K791183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: D205F7
• Device Catalogue Number: D205F7
• Device Lot Number: 62604741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1