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

Model Number D134804

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 11/03/2022

Event Type  Injury  

Event Description

It was reported that a 65 year-old-male patient underwent a atrial fibrillation (afib) ablation procedure with a two (2) thermocool® smart touch® sf bi-directional navigation catheters and the patient suffered a cerebrovascular accident (stroke).It was reported that after an afib case, a possible stroke was noticed.There were no visible signs on the patient during the procedure.During the procedure there were spikes in impedance.They checked the irrigation was functioning properly on the catheter with no resolution.The catheter was removed from the body and char was discovered at the tip of the catheter.They changed the catheter and continued the procedure.Approximately an hour in a half after the procedure the patient was reported to have stroke like symptoms.The patient was experiencing motor issues on his right leg and arm and a droopy mouth.The patient has remained stable and had not worsened.The stroke was unable to be confirmed by computed tomography (ct) and patient is awaiting an magnetic resonance imaging (mri) scan.The medical intervention provided was heparin and observation.The physician is not ruling out the char or the catheter as the cause of the possible stroke but could not confirm.Additional event information was received indicating the physician¿s opinion on the cause of the adverse event can be multifactorial given the risks associated with the procedure and he does not consider the event was caused solely by the catheter, but charring and coagulation at the tip could have been a precipitating factor and cannot be ruled out.Patient¿s outcome is improved - the last update from the clinical team was provided on (b)(6) 2022 and it was confirmed that after mri imaging a stroke was confirmed (no details were provided on the exact location in the brain) and upon neurological assessment, the motor affectation persists on the patient's right leg only.The patient required extended hospitalization to evaluate further with mri imaging, and neurological monitoring.Char located on tip electrode.During the ablation we had 2 impedance spike alerts and the system immediately stopped the ablation.No issues related to temperature and flow on the catheter.The moment of the impedance spikes the system was on temperature control mode with the following parameters: 40 watts / 50 c.After the catheter was removed and exchanged the parameters were switched to power control mode.40 watts.Max temp was 54 c, impedance was 143 average and the impedance spikes were the first one of 62 ohms and the second one was 85 ohms.Anticoagulation was given and the act was monitored throughout the case to maintain greater than 300 seconds.Patient has not exhibited any neurological symptoms since the procedure was completed.At the moment of the impedance spikes the system was on temperature control mode with the following parameters: 40 watts / 50 c.After the catheter was removed and exchanged the parameters were switched to power control mode.40 watts.The impedance cutoff was 190 ohms.Force visualization features were graph, dashboard, vector, visitag.Visitag stability parameters were range: 3mm, time: 3 sec, force over time (fot) of 25%, 3g.No additional filters were used.Ablation index color option was used.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.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.Biosense webster manufacturer's reference number (b)(4) has two reports: product code d134804 (thermocool® smart touch® sf bi-directional navigation catheters).(2) mfr # 2029046-2022-03028 for product code unk_smart touch unidirectional sf (thermocool® smart touch® sf bi-directional navigation catheters).

Manufacturer Narrative

On 2-dec-202, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a 65 year-old-male patient underwent a atrial fibrillation (afib) ablation procedure with a two (2) thermocool® smart touch® sf bi-directional navigation catheters and the patient suffered a cerebrovascular accident (stroke).It was reported that after an afib case, a possible stroke was noticed.There were no visible signs on the patient during the procedure.During the procedure there were spikes in impedance.They checked the irrigation was functioning properly on the catheter with no resolution.The catheter was removed from the body and char was discovered at the tip of the catheter.They changed the catheter and continued the procedure.Approximately an hour in a half after the procedure the patient was reported to have stroke like symptoms.The patient was experiencing motor issues on his right leg and arm and a droopy mouth.The patient has remained stable and had not worsened.The stroke was unable to be confirmed by computed tomography (ct) and patient is awaiting an magnetic resonance imaging (mri) scan.The medical intervention provided was heparin and observation.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage, anomalies, or char was observed on the device, nor was it reported by the decontamination site.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, the force hi alert and current leakage during the electrical test were observed due to corrosion on the sensor, electrical and connector printed circuit boards (pcb).In addition, the product was deflecting and irrigating correctly.It was determined that the corrosion condition may be related to the electrical and force failures observed during the investigation, and the high impedance issue described by the customer.During the product evaluation process, the lot number was verified to be 30897965l.Based on the lot number, the manufacturing date was determined to be 8-sep-2022 and the expiration date 7-sep-2025.With the lot number available, a manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The char issue reported by the customer could not be replicated during the product investigation.It should be noted that product failure is multifactorial.The root cause of the adverse event remains unknown, force and electrical issues regarding the product were found during this investigation but based on the information available they were unrelated to the event described.The high impedance issue reported by the customer was confirmed.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported issues of char and adverse event.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: circuit board (g02005) and connector/coupler (g04034) were selected as related to the hi impedance issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15904535
• MDR Text Key: 304687179
• Report Number: 2029046-2022-03027
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30897965L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2022
• 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; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; UNK_SMART TOUCH UNIDIRECTIONAL SF
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male