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

Model Number 774HF75

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

Patient Problems Mitral Valve Stenosis (1965); Tricuspid Regurgitation (2112)

Event Date 07/31/2017

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.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.Kinking, looping and knotting are potential complications that are discussed in the product instructions for use (ifu).In this journal article it was stated that knotting of the catheter was thought to be the result of repeated advancing and pulling of the catheter.As no device malfunction was identified at the time of the documentation of this mdr, no corrective actions will be taken at this time.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

Per the journal of cardiovascular anesthesia, 2015; 19: suppl: 309: a patient was undergoing mitral valve replacement (mvr) and tricuspid annuloplasty (tap) to correct mitral valve stenosis and tricuspid regurgitation.The swan ganz catheter was inserted from the right internal jugular vein and positioned to the pulmonary artery.When the tricuspid valve was manipulated, the catheter was pulled back to the central vein.When weaning from the cardio-pulmonary bypass (cpb), the clinician attempted to re-advance the catheter to pulmonary artery, but it was difficult to pass the tricuspid valve.Several attempts were made utilizing transesophageal echocardiography (tee) but the clinician was unable to pass the tricuspid valve.The catheter was also unable to be removed.The clinician was informed that there is a possibility of the pac forming a knot, and the knot was actually confirmed by palpating from the patient skin.It was suspected that the knot was formed during manipulation of the catheter.After the chest was closed, the knot was confirmed in the right internal jugular vein by x-ray.The next day, the catheter was removed with the introducer.The catheter was removed by making a few millimeter skin incision.Knotting of the catheter was confirmed and thought to be the result of repeated advancing and pulling of the catheter.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES,PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6820474
• MDR Text Key: 83644913
• Report Number: 2015691-2017-02625
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 774HF75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 43