MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

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

Patient Problems Tachycardia (2095); Thrombosis (2100)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 11/14/2019.Initial visual analysis observed there was no visual damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient underwent a persistent atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention, thrombosis and tachycardia.During the procedure, during the transseptal phase, the attending and the fellow had completed first transseptal puncture, with the ablation catheter across and were working on getting the second transseptal puncture.The physician and fellow were working strictly with an intracardiac echocardiogram (ice) to achieve the transseptal puncture.While working through multiple ice views with the second transseptal needle, the physician postulated that he saw a view in which the needle had jumped into the right atrial appendage and that is where the potential perforation happened.The attending immediately noticed a severe drop in heart rate (down to 28 bpm) with accompanying hypotension.The fellow used the ice to confirm cardiac tamponade due to the pericardial effusion from accidental transseptal needle puncture.A pericardiocentesis was performed and 1500cc of fluid/blood was removed with about 1l reinfused back into the patient.The patient stabilized for about 30 minutes until the attending noticed what looked like a large clot swirling around in the right atrium.Shortly after, the patient¿s heart rate went tachycardic and blood pressure dropped.The decision was made to get the patient to cardiac surgery for puncture repair following this further complication.The puncture was discovered in the right ventricle, where a few stitches were placed to close the hole.The only bwi products in the patient at the time of cardiac tamponade was the decanav (in the coronary sinus), the soundstar catheter (utilized for ice), and the stsf ablation catheter (which was across the first transseptal in the left atrium).The patient was hospitalized for about a week post-surgical intervention before being discharged.Their condition has improved.Patient has a history of stroke prior to procedure.A transesophageal echocardiogram was performed before the procedure and there was no evidence of clots or prior effusion.Transseptal puncture was performed with a 71 cm brk needle manufactured by st.Jude.No ablation had been performed prior to the cardiac tamponade.Flow settings were the smart touch® sf standard settings.Graph, dashboard, vector, and visitag force visualization features were used during the procedure, even though no ablation was performed.Visitag parameters were max distance change 2 mm, minimum time 3 sec, force over time at 100% with a minimum force of 1 gram, tag size at 3 mm and tag index (surpoint) for coloring.--- no additional filters were used with the visitag parameters.There were no error messages observed on biosense webster equipment prior to or during the event.The cardiac tamponade event was related to use of the transseptal needle.The puncture was discovered in the right ventricle where no product was used specifically.It is possible that the location of the transseptal needle may have slipped into the right ventricle.As such, bwi will exclude involvement of bwi devices in the cardiac tamponade incident.

Manufacturer Narrative

On 11/27/2019, it was noticed that the concomitant products were inadvertently omitted from the 3500a initial medwatch.Concomitant med products has now been populated with the following products: carto 3 system, decanav catheter, soundstar catheter, st.Jude 71 cm brk transeptal needle.

Manufacturer Narrative

It was reported that a female patient underwent a persistent atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention, thrombosis and tachycardia.During the procedure, during the transseptal phase, the attending and the fellow had completed first transseptal puncture, with the ablation catheter across and were working on getting the second transseptal puncture.The physician and fellow were working strictly with an intracardiac echocardiogram (ice) to achieve the transseptal puncture.While working through multiple ice views with the second transseptal needle, the physician postulated that he saw a view in which the needle had jumped into the right atrial appendage and that is where the potential perforation happened.The attending immediately noticed a severe drop in heart rate (down to 28 bpm) with accompanying hypotension.The fellow used the ice to confirm cardiac tamponade due to the pericardial effusion from accidental transseptal needle puncture.A pericardiocentesis was performed and 1500cc of fluid/blood was removed with about 1l reinfused back into the patient.The patient stabilized for about 30 minutes until the attending noticed what looked like a large clot swirling around in the right atrium.Shortly after, the patient¿s heart rate went tachycardic and blood pressure dropped.The decision was made to get the patient to cardiac surgery for puncture repair following this further complication.The puncture was discovered in the right ventricle, where a few stitches were placed to close the hole.The only bwi products in the patient at the time of cardiac tamponade was the decanav (in the coronary sinus), the soundstar catheter (utilized for ice), and the thermocool® smart touch® sf bi-directional navigation catheter (which was across the first transseptal in the left atrium).The patient was hospitalized for about a week post-surgical intervention before being discharged.Their condition has improved.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.The force sensor was tested and it was working properly, the force values were observed within specifications.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed for the finished device [30262359m] number, and no internal actions related to the reported complaint condition were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9380754
• MDR Text Key: 168438907
• Report Number: 2029046-2019-03939
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

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 Expiration Date: 08/01/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30262359M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 12/30/2019
• Supplement Dates FDA Received: 11/27/2019; 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; DECANAV CATHETER; SOUNDSTAR CATHETER; ST. JUDE 71 CM BRK TRANSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 60