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 Heart Block (4444)

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported that a male patient born (b)(6) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered heart block requiring a pacemaker implantation.During the idvt case, after having completed 4 ablation applications and working on the low septal av section, the patient suddenly went into heart block.They utilized rv pacing, and all other possible ablations were stopped.Monitor the patient for about 1hr after the incident to see if the patient would recuperate; recuperation happened slowly, 3:1 and 2:1 after some time but never regained 1:1 conduction.The physician decided to install a pacemaker and will be completed soon.The patient appears to be in stable condition at this time.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure/patient condition.Patient outcome of the adverse event: fully recovered.The patient was to be kept overnight for observation.Patient was monitored in the lab for approximately 2hours.In this time, his heart block resolved without further intervention.Generator used biosense webster: smartablate generator.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it may require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

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).

Manufacturer Narrative

On 28-dec-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2022, the product investigation was completed.It was reported that a male patient born (b)(6) 1955 (210lbs) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered heart block requiring a pacemaker implantation.During the idvt case, after having completed 4 ablation applications and working on the low septal av section, the patient suddenly went into heart block.They utilized rv pacing, and all other possible ablations were stopped.Monitor the patient for about 1hr after the incident to see if the patient would recuperate; recuperation happened slowly, 3:1 and 2:1 after some time but never regained 1:1 conduction.The physician decided to install a pacemaker and will be completed soon.The patient appears to be in stable condition at this time.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A deflection test, screening test, magnetic sensor functionality test, temperature and impedance test, electrical test, coolflow pump test, patency flow test were performed, and the device performed correctly, no issues were observed.Per the event, several tests were performed.The 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 30657081l number, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The instruction 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 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: 13085852
• MDR Text Key: 287613519
• Report Number: 2029046-2021-02245
• 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,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30657081L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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): Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG