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

Model Number	D132704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/31/2021
Type of Reportable Event	Death
Additional 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient ((b)(6) kg, 176cm) underwent an ischemic ventricular tachycardia (isvt-left) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and death.The doctor was performing the lateral wall ablation of the left ventricle, during the ablation he noticed that the cavity was perforated by the catheter.Therefore, they did a pericardial drainage to stop the bleeding.Few seconds later it bled again so they decided to perform an open chest cardiac surgery where they saw that the main bleeding focus was the laceration of the subclavian vein where the anesthesiologist inserted the central catheter through that vein.The patient died because they could not stop that bleeding.Surgery was delayed due to the reported event and the procedure was not successfully completed.The patient had an implantable cardiac defibrillator and a previous ablation of ischemic ventricular tachycardia in 2012 due to an acute myocardial infarction.On 3-sep-2021, additional information was later received which indicated the adverse event was discovered during use of biosense webster inc.Products, during the ablation phase.No error messages were observed on biosense webster equipment during the procedure.Physician¿s opinion on the cause of death was that there was a laceration of the subclavian vein by the insertion of the central catheter performed by the anesthesiologist.During the last second of the ablation the catheter pressure was 50 gr but there was no clinical evidence of a steam pop.The heart was indeed perforated, however, it was successfully plugged and it was not the death cause of the patient.The correct catheter settings selected on the generator and the irrigation pump was switching from ¿low¿ to ¿high¿ flow during ablation.The irrigated catheter settings was 30 ml.Force visualization features were graph, dashboard, vector and visitag.Visitag module parameters for stability used were 3mm / 3 seconds.Additional filters used with visitag were force over time (fot) of 25% over 3 gr.Color options used were force time intervel (fti) 25% over 3 gr, average 35 gr, force 20 gr, time 33 sec.On 23-sep-2021, additional information was received indicating the heart was indeed perforated, however, it was successfully plugged and it was not the cause of death of the patient.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12538212
• Report Number: 2029046-2021-01638
• Device Sequence Number: 4080224
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Health Professional
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; ST. JUDE TRANSSEPTAL NEEDLE; UNKNOWN GENERATOR; UNKNOWN PUMP
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82