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 10/25/2022

Event Type  Injury  

Manufacturer Narrative

An analysis of the product could not be performed since a physical sample was not received for evaluation.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient aged around 70-80 years and weighing 120 lbs.Underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) and cardiac arrest requiring pericardiocentesis and cardiopulmonary resuscitation (cpr).It was reported that during a right atrial tachycardia ablation, the patient suffered a perforation and pericardial effusion (pe).The physician was ablating excessively in one area of the right atrium (ra) when the perforation occurred.There was a decrease in patient blood pressure and intracardiac echo (ice) revealed the effusion.A pericardiocentesis was performed, cpr was administered.The bwi representative had to leave the ep lab during intervention, no further information was available other than the patient recovered and was stable.It was undetermined if the physician believed that bwi products contributed to the event.The device is not available for return.An octaray catheter was also used in the procedure.Additional information received on 07-nov-2022.The adverse event was discovered after use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was patient condition related and fellow manipulating the sheath.The patient fully recovered and was discharged the next day.Relevant tests/laboratory data -none.Other relevant history -none.Generator information-smart ablate system rf generator, model: m490002 with serial number sn: (b)(4).Transseptal puncture was not performed.Ablation was performed prior to noting the pe or ct.There was no evidence of steam pop.The event occurred after ablation of the area of interest.The flow setting for the irrigated catheter used was 15 ml.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used was graph, dashboard; vector; visitag.Parameters for stability for the visitag module used 3mm at 3sec ;25% over 3 grams; 3mm tag size; additional filter used with the visitag was impedance coloring 0-10ohms.Color options used was impedance drop.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

Manufacturer's reference number: (b)(4) during an internal review on 22-nov-2022, it was noted that the physician's contact information was inadvertently omitted from the initial 3500a report mwr-03112022-0001291523.Therefore, section e - initial reporter section was updated on this report.

• 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: 15850104
• MDR Text Key: 304177250
• Report Number: 2029046-2022-02924
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SPARE-US; UNK_CARTO 3; UNK_OCTARAY NAV
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG