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

Model Number 744F75

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Thrombus (2101)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.It is unknown if user or procedural factors contributed to the stated event.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No 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 is well described in the literature.It is stated in the ifu that complications include but are not limited to thrombosis.In this case the patient was considered recovered from the 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 the patient developed a thrombus in the right atrium.The thrombus was observed on the first day of use in aortic valve replacement (avr) surgery to treat aortic stenosis.The catheter was inserted and the catheter position was checked.Echocardiography showed a thrombus (~ one centimeter-long ) in the right atrium.The thrombus was removed by opening the right atrium.One return cannula was originally planned to be used via superior vena cava in the surgery, but two return cannulas were used due to the event.Avr surgery was completed as planned.The clinician assessed that the event could not lead to death or disability.It did not require inpatient hospitalization or result in prolongation of existing hospitalization to treat the event.The event was considered to be related to the catheter.The patient is a (b)(6) year old female with no medical history of abnormality of coagulation function.Patient status was defined as the patient was recovered from the event.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER
• 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: 9819355
• MDR Text Key: 190979552
• Report Number: 2015691-2020-10885
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K924452
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 45