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 Problem Cardiac Tamponade (2226)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that while ablating the atrial flutter line in the left atrium, there was a pericardial effusion that was confirmed via intracardiac echocardiography (ice) towards the end of the procedure.There was no real indication of a steam pop or high force and they are unsure of where it may have happened.The physician thinks it may have occurred when he was placing the bard coronary sinus (cs) catheter.They removed all catheters from the patient, did a pericardiocentesis, reversed anti-coagulation, and there was initially 300cc of fluid removed.They were unable to stop the bleeding into the pericardial space.The patient went to the operating room (or) for surgical repair.The patient was stable post-surgical repair when they left for the or.It was reported the doctor stated they were having a difficult time getting the cs catheter in place and they think they may have perforated then.Additional information was later received indicated the adverse event was discovered during use of biosense webster products, during the ablation phase.The physician¿s opinion on the cause of this adverse event is that it was the procedure related.The medical intervention provided pericardiocentesis and surgical closure of the perforation.The outcome of the adverse event was reported as improved.Patient required extended hospitalization because of the adverse event due to surgery.A smartablate generator with correct catheter settings.A transseptal puncture was performed with a st jude transseptal needle with brockenbrough method.Prior to noting the cardiac tamponade ablation was already performed.There was no evidence of steam pop.An irrigated catheter was used in the event with the flow setting at 15 cc/min.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were included graph, dashboard, vector, and visitag.The visitag module was used, the parameters for stability used were range: 2mm, time: 3 seconds, force over time of 40%; 5g and 3mm tags.No additional filter was used with the visitag.The color option used prospectively was surpoint tag index.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13086382
• MDR Text Key: 282770894
• Report Number: 2029046-2021-02249
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2021

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: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; BARD DYNAMIC TIP DECA-POLAR CS CATHETER; CARTO 3 SYSTEM; PENTARAY F CURVE CATHETER; REPROCESSED STERILE MED SOUNDSTAR CATHETER; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; ST. JUDE TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female