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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered cerebrovascular accident and cardiac arrest.It was reported that during the case, it was suspected that the patient had a stroke.The patient began groaning loudly and the physician suspected a stroke was happening at that time.The patient's ejection fraction (ef) was already 10% prior to the procedure and already in heart failure prior to the procedure.While mapping the left atrium the patient became pulse-less (asystole) and her blood pressure was nonexistent.They did chest compression, and a balloon pump, and put the patient in an ecmo (extra corporeal membrane oxygenation).One ablation was completed on the right atrium.They were less than 10 minutes at the left atrium.Ablation was completed after all of this was going on.The physician wanted to see if they could stop the arrhythmia.Her heart had electrical activity but was not beating.The medical team stated that after noticing the possible stroke there was just a moment after the heart stopped beating and chest compression began.The physician checked for an effusion but none was found.The reason for the possible stroke is unknown.Afterward, the patient achieved stable condition.Their arrhythmia was managed with drugs.The patient required extended hospitalization--and they had already been hospitalized 4 weeks prior to the procedure and already had heart failure.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.

Manufacturer Narrative

On 11-oct-2023, the product investigation was completed.It was reported that a patient underwent a atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered cerebrovascular accident and cardiac arrest.It was reported that during the case, it was suspected that the patient had a stroke.The patient began groaning loudly and the physician suspected a stroke was happening at that time.The patient's ejection fraction (ef) was already 10% prior to the procedure and already in heart failure prior to the procedure.While mapping the left atrium the patient became pulse-less (asystole) and her blood pressure was nonexistent.They did chest compression, and a balloon pump, and put the patient in an ecmo (extra corporeal membrane oxygenation).One ablation was completed on the right atrium.They were less than 10 minutes at the left atrium.Ablation was completed after all of this was going on.The physician wanted to see if they could stop the arrhythmia.Her heart had electrical activity but was not beating.The medical team stated that after noticing the possible stroke there was just a moment after the heart stopped beating and chest compression began.The physician checked for an effusion but none was found.The reason for the possible stroke is unknown.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31060689l and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was the patient condition.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17897395
• MDR Text Key: 325242714
• Report Number: 2029046-2023-02261
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31060689L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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; Hospitalization; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female