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 Perforation (2513); Pericarditis (4448)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that an 80-year-old male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac perforation and pericarditis requiring prolonged hospitalization.During a pvc idvt case, a cardiac perforation was noticed.There were no visible signs on the patient but during mapping, they noticed they were in the epicardial space although this was not for an epicardial case.The perforation was confirmed by echo and when they checked on intracardiac echo (ice) they found a 1 cm pericardial effusion.No medical intervention was provided because the patient was stable the entire time.The case was aborted, and the patient was continued to be monitored.The patient was reported to be in stable condition at the time of the call.The physician could not confirm the cause of the injury.The physician¿s opinion on the cause of this adverse event was he doesn¿t believe it was due to malfunction of bwi products.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.No intervention was required during effusion but the patient developed acute pericarditis and required management in hospital.A transseptal puncture was performed with a brk-1.No ablation was performed during case.The irrigated catheter flow setting was set at tko (to keep open) 2cc during entire case.The correct catheter settings were selected on the generator.Force visualization features were used were graph, dashboard and vector.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could 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

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 reference number: (b)(4).

Manufacturer Narrative

On 8-jul2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an 80-year-old male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac perforation and pericarditis requiring prolonged hospitalization.Device evaluation details: 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 30764637l, and no internal action was found during the review.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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14710926
• MDR Text Key: 294942767
• Report Number: 2029046-2022-01336
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30764637L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2022
• 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: BRK-1 TRANSEPTAL NEEDLE.; CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; SMARTABLATE PUMP.; TKO 2CC IRRIGATED CATHETER.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male