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 Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2022, 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient born on (b)(6) 1947 underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade and cardiac arrest requiring pericardiocentesis and cardiopulmonary resuscitation (cpr).It was reported that shortly after the transseptal puncture the patient went hypotensive.It was confirmed by intracardiac echocardiography (ice) the patient had a tamponade.A pericardiocentesis was done.They are unsure of how much blood was removed; they think it may have been one liter of blood removed.The patient's blood pressure was not present, and cpr was performed until the pericardiocentesis was done.The caller is unsure if the patient required surgical repair.They state that when they left the patient was stable.They had done the cavotricuspid ishmus (cti) ablation prior to getting the transeptal access.They used 30 watts.They used the thermocool® smart touch® sf bi-directional navigation catheter (stsf), a vizigo sheath, and an acunave ultrasound catheter.The physician did not say what may have been the issue.His concern was the transseptal access.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The patient outcome of the adverse event is improved.The patient did require extended hospitalization because of the adverse event, they stayed for overnight observation.A smartablate generator was used in this case.A baylis nag transeptal needle was used.There was no evidence of steam pop.An irrigated catheter was used in the event, the flow setting was 8.Correct catheter settings were selected on the smartablate generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Dashboard and vector force visualization features were used.Parameters for stability for visitag were range: 2mm and time: 3sec.Respiration setting was an additional filter was used with the visitag.Impedance drop color option was used prospectively.

Manufacturer Narrative

It was reported that a male patient born on (b)(6) 1947 underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade and cardiac arrest requiring pericardiocentesis and cardiopulmonary resuscitation (cpr).It was reported that shortly after the transseptal puncture the patient went hypotensive.It was confirmed by intracardiac echocardiography (ice) the patient had a tamponade.A pericardiocentesis was done.They are unsure of how much blood was removed; they think it may have been one liter of blood removed.The patient's blood pressure was not present, and cpr was performed until the pericardiocentesis was done.The caller is unsure if the patient required surgical repair.They state that when they left the patient was stable.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.On 24-nov-2022, the lot number (30863687l) was able to be obtained/verified though the product evaluation process.As such, field d4.Lot has been populated with this number and manufacturing date of 27-jul-2022 and expiration date of 26-jul-2025 have been populated into fields d4.Expiration date and h4.Device manufacture date.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, 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 batch number, and no internal actions were identified.No malfunction was observed during the product analysis.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.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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15594358
• MDR Text Key: 301631155
• Report Number: 2029046-2022-02508
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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
• Device Lot Number: 30863687L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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: BAYLIS NAG TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male