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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that an (b)(6) female patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis, cardiac arrest and cardiac tamponade requiring pericardiocentesis.It was reported that towards the end of the case the physician verified there was a pericardial effusion via the ultrasound.The catheter was in the right ventricle where the pericardial effusion was seen as being moderate.The patient had st elevations and then they went into a pulseless electrical activity rhythm.The doctor and the technologist then performed chest compressions for about two minutes.A pericardiocentesis was done.There was 90 cc of fluid that was removed.The echo showed that a clot had formed.The patient became more hemodynamically stable after pericardiocentesis.A request was made for a cardiac surgery consult for surgery for the removal of the clot.It was determined the patient did not need emergent surgery for removal of the clot.The patient was then transferred to the cardiac intensive care unit where they were still intubated but stable.The patient remained in hospital for extended care.Patient was observed overnight, the clot in the pericardium was observed to ensure resorption into the body.Patient maintained sinus rhythm but was held for approximately a week for observation and diuresis.The physician is unsure what may have caused the issue.The ablations that were done in the procedure were: pulmonary vein isolation, posterior wall isolation, and a mitral isthmus line.The mitral isthmus line consisted of ablation along the anterior wall of the left atrium with anchors on the mitral valve and the left upper pulmonary vein.The was also a cti ablation done as well.The caller states the physician is unsure what may have caused the issue.The caller states that during ablation there was a steam pop during the cti ablation.All ablations were done at 50 watts from the left atrium to the cti across both chambers.It was noted there may have been ablation done near the ivc or under the cti, they are unsure, for approximately 49 seconds.It is unclear if this is the case.The physician did make note of this and it was discussed.Transseptal puncture performed with extra sharp brk needle.The force visualization features used included dashboard, vector and visitag.Visitag module was used, the parameters for stability were, range: 3 mm, time: 3s, force over time (fot) 25% at 3 gm, tag size 3mm.No additional filters.Ablation flow settings ml/min flow rate, 15ml/min during 50w ablations.Flow ramp rates were set to their normal, default settings.It was switching to high flow during ablation.There were no error messages on biosense webster equipment during the procedure.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the complaint device for evaluation.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.Upon receipt, the lot number was verified to be 30470903m.This was verified by electronically erasable programmable read only memory (eeprom) file.Field d4.Lot has been populated with this number.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that an 86-year-old female patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis, cardiac arrest and cardiac tamponade requiring pericardiocentesis.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the device.Visual analysis of the returned product revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.Magnetic, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 11458143
• MDR Text Key: 243964542
• Report Number: 2029046-2021-00346
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30470903M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; EXTRA SHARP BRK
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR