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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.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.Values should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to abort further attempts to obtain the value(s) in question, 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.

Event Description

It was reported that during use of a swan-ganz catheter with a hemisphere monitor, there was an extremely low right ventricular ejection fraction (rvef) value displayed of 9%.All the other parameters provided by the swan-ganz catheter were ¿ok¿.It was specified that the patient had mild/moderate atrial insufficiency (ai), severe mitral regurgitation (mr), mild/moderate tricuspid regurgitation (tr), moderately dilated left ventricle (lv), dilated right ventricle (rv) on tee, rvef on transesophageal echocardiography (tee) via simpson's method was 47%, tricuspid annulus plane systolic excursion (tapse) was 0.8, and infusions via right internal jugular cvc were a total of 68 ml/hr.Catheter placement was checked and was confirmed to be correctly placed.The edwards sales representative was present during the procedure and confirmed the user followed all steps correctly.There was no allegation of patient injury.The device was still in use at the time the complaint was reported; however, the hospital discarded the catheter after it was removed.

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: 9191991
• MDR Text Key: 194364129
• Report Number: 2015691-2019-03783
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61689336
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 58