MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774F75

Device Problems Incorrect Measurement (1383); 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 09/12/2019

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 the device met all specifications upon distribution.

Event Description

It was reported that during use of a swan-ganz catheter, the displayed right ventricular ejection fraction (rvef) value was 28%, which was not consistent with the clinical picture.The tricuspid annular plane systolic excursion (tapse) ¿looked good¿ on tee (transesophageal echocardiography); however, the issue could not be resolved with the assistance of edwards tech support.No error messages were displayed.The patient was not treated based on the incorrect values and there was no patient injury.Demographics were requested and not provided.

Manufacturer Narrative

Our product evaluation laboratory received one model 774f75 swan-ganz catheter with a 1.5cc monoject syringe and a non-edwards contamination shield.The catheter was received inserted in a non-edwards contamination shield.The catheter ran cco in a 37.0°c water bath for 5 timed minutes without error on a vigilance ii monitor.The thermistor and thermal filament circuit were continuous and there were no open or intermittent conditions.No visible inconsistency was observed on eeprom data.The resistance value of the thermal filament circuit was measured at 35.90ohms, which was within specification.The catheter was submerged in a 37.0°c water bath and read 37.0°c on the vigilance ii monitor.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.All through lumens were patent without any leakage or occlusion; however, the non-edwards contamination shield was removed and the catheter body was found collapsed under the proximal connector, approximately 74cm from the distal tip.No other visible damage was observed from the catheter body, the balloon or the returned syringe.The customer report of low rvef was not confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the 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, values can change quickly and dramatically and should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort further efforts to obtain readings and the catheter can be exchanged if desired.It is unknown whether user or procedural factors 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

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9136636
• MDR Text Key: 188732826
• Report Number: 2015691-2019-03633
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61561768
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1