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

Model Number D134804

Device Problems High Readings (2459); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/30/2020

Event Type  Death  

Manufacturer Narrative

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 was performed for the finished device 30430125l number, and no internal action related to the complaint was found during the review.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.(b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient with history of cardiomyopathy, underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.Physician mapped a right ventricle ectopic with the thermocool® smart touch® sf bi-directional navigation catheter.Mapping phase was successfully completed.After that, with the interest zone delimited in carto 3 system, physician decided to deliver radiofrequency to the right ventricle outflow tract (rvot) at 50w in power control mode with a smartablate generator.The physician was warned about delivering too high power but decided to continue.The force was monitored during the ablation phase and high contact force values (30g, 40g¿) were shown in the carto 3 screen.The physician was notified about the high force readings.The patient¿s blood pressure dropped, and cardiac tamponade was confirmed.Physician performed an emergency pericardiocentesis, but the patient did not recover and was transferred to surgery.An open-hear surgery was performed.Despite all efforts, the patient died.Physician causality opinion was not provided.Transseptal puncture was not done.No evidence of steam pop during the ablation was observed.The catheter flow was set at 17ml/min at 50 watts.The parameters for stability used with the visitag module were range: 3mm ¿ time: 3s, force over time (fot) 25% - 3grams.Tag size: 3.

• 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
• 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: 11074818
• MDR Text Key: 223702200
• Report Number: 2029046-2020-01985
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30430125L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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: CARTO 3 SYSTEM.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 67 YR