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

Model Number D134805

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

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 02/16/2022

Event Type  Death  

Event Description

It was reported that a (b)(6) year-old male patient ((b)(6) kg) underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient died twelve (12) hours after the procedure.Twelve hours after the case the patient expired, the patient had an impela and after the ablation they repositioned the impela and caused a lot of ectopy.The patient went into ventricular fibrillation (vf) that they couldn't convert.The physician¿s opinion on the cause of this adverse is patient condition and placement of the impella.Intervention provided was cpr and shocks given post case, but patient's status did not decline until hours after.The patient was very sick and was intubated before case.The first part of case was to replace impella since it was "clotting".The doctor believes the replacement of impella was the main cause of this death.A smartablate generator was used in the procedure.The date of death was (b)(6) 2022.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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 reference number: (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; 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: 13754425
• MDR Text Key: 287100648
• Report Number: 2029046-2022-00522
• 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: Other
• Type of Report: Initial
• Report Date: 03/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• 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
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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: SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Death
• Patient Sex: Male
• Patient Weight: 110 KG