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 Tamponade (2226); Cardiogenic Shock (2262)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.A patient suffered a cardiogenic shock and a cardiac tamponade requiring a pericardiocentesis.Pvi and cti were performed for paf.The patient became a state of shock after two hours after returning to the ward.Pericardiocentesis was performed, and the patient is being followed up.Atrial septal puncture was performed by rf needle.Ablation was performed before tamponade was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting was within the recommended range.The physician's opinions on the relationship between the event and the product were that the patient became a state of shock thought to be hemorrhagic, but when pericardiocentesis was performed, the amount of blood was small.Therefore, they decided that thoracotomy would not be performed and also decided that the relationship of the event and the product is that judging from the amount of bleeding and area of bleeding, they thought the his catheter of another company's product was the cause.At present, the patient is being followed up in the intensive care unit (icu).No abnormalities were observed prior to use or during of the product.Additional information was received.The physician¿s opinion on the cause of this adverse event was the procedure.The patient is being followed up in the icu.Rf needle was used.They used the flow setting that was recommended.Force visualization features used were real time graph; dashboard; visitag.Color options used prospectively was tag index.¿state of shock"" statement means that the patient went into shock.

Manufacturer Narrative

Initial reporter phone: (b)(4).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

Additional information was received on 26-jan-2023.Patient did not require extended hospitalization because of the adverse event.Smartablate generator was utilized.Correct catheter settings were selected on the generator.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.The visitag module was used, what parameters for stability were the recommended setting.No additional filter was used.No error on the carto3 system.The lot number could not be confirmed because it was discarded at the hospital.Therefore, updated the following fields: d10.Concomitant medical products and therapy dates added unk_smartablate generator and unknown brand pump h6.Type of investigation from ¿device not returned (b17)¿ to ¿device discarded (b18)¿ 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15944271
• MDR Text Key: 305143862
• Report Number: 2029046-2022-03062
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• 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: CARTO 3 SYSTEM WITH CARTO MERGE; PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN BRAND PUMP; UNKNOWN BRAND RF NEEDLE; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male