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

Model Number 777F8

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

Patient Problems Ventricular Fibrillation (2130); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

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.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.Cardiac arrhythmia is listed in the ifu as a potential complication of swan ganz catheter.Cardiac arrhythmias may occur during insertion, withdrawal, and repositioning, but are usually transient and self-limited.Premature ventricular contractions are the most commonly observed arrhythmia.Ventricular tachycardia and atrial tachycardia have been reported.Use of prophylactic lidocaine should be considered to decrease the incidence of ventricular arrhythmias during catheterization.Ecg monitoring and immediate availability of antiarrhythmic drugs and defibrillator equipment is recommended in this case, the patient experienced that the pulmonary artery catheter manipulation during the surgery induced vf in this case but patient status post-surgery was well.It should be taken into consideration that patients with bifascicular block have a risk of severe circulatory failure in association with the catheter manipulation.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

Information was obtained from the journal article ¿a case of vf induced by pulmonary artery catheter manipulation¿ cardiovascular anesthesia 23: suppl(cd-rom) rombunno.Dp1-2-06.The patient is a (b)(6) year old male with a medical history of severe aortic insufficiency, first degree atrioventricular block, complete right bundle branch block and left anterior fascicular block.There were no obvious coronary artery lesions.Bentall procedure was planned for severe aortic insufficiency.The patient was receiving treatment with an i-c group antiarrythmic medicine.A swan ganz catheter was inserted via right internal jugular vein while induction of general anesthesia.The catheter tip was attempted to be placed at the right pulmonary artery by transesophageal echocardiographic guidance, but it could not be advanced.The monitoring was initiated with the catheter tip located near bifurcation of the pulmonary trunk.Cardiopulmonary bypass was introduced without problem and bentall procedure was performed as planned.Ventricular fibrillation (vf) was observed after de-clamping the aorta, but it was returned to sinus rhythm following the first defibrillation attempt at 2j.The procedure progressed without problem with the support of catecholamine and the cardio-pulmonary bypass was weaned 39 minutes after the aortic blockage was released.After the removal of a return cannula, the catheter position was attempted to be changed under radiographic guidance while a perfusion cannula remained to be placed.However, the catheter tip was difficult to be moved forward to the right pulmonary artery.Another episode of vf was developed during several attempts of the catheter placement.The defibrillation had no effect on the vf.The return cannula was inserted again and cardiopulmonary bypass was reintroduced while performing cardiac massage.Thereafter the vf was returned to sinus rhythm following several defibrillation attempts.The cause investigation indicated that myocardial ischemia or electrolyte imbalance could be excluded as the possible cause of the event.It was determined that it is highly likely that interruption of impulse transmission by the catheter as well as underlying bifascicular block induced the event.It was decided to pull back the catheter to the superior vena cava and the cardio-pulmonary bypass was weaned.The operation was completed without problem and the postoperative course was satisfactory.The patient experienced that the pulmonary artery catheter manipulation during the surgery induced vf in this case.It should be taken into consideration that patients with bifascicular block have a risk of severe circulatory failure in association with the catheter manipulation.Patient status was defined as patient is doing well after the surgery.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV 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: 9820263
• MDR Text Key: 190978580
• Report Number: 2015691-2020-10889
• 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
• Report Date: 02/18/2020

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: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 85