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

Catalog Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 10/06/2023

Event Type  Death  

Manufacturer Narrative

B2.Date of death - the exact date of death is unknown at this time and so this field was populated with the awareness date.The device has been reported as discarded, 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.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 patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure using a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac tamponade that required pericardiocentesis, cpr and surgical intervention but ultimately passed away.While mapping and ablating for afib, a steam pop occurred and subsequently, the patient developed a pericardial effusion.The physician was first mapping an anatomical pouch in the left atrium, located near the roof close to the left superior pulmonary vein.Radiofrequency (rf) delivery began, and an impedance drop was noted, the physician also heard a "pop." rf delivery was immediately stopped, and they checked on intracardiac echo for an effusion, which was confirmed (later the effusion was reconfirmed using transthoracic echo).They waited for two minutes to see if the effusion was worsening, and in that span of time the patient crashed, blood pressure dropped, and cpr was administered.A code was called.A pericardiocentesis was performed and when they started to drain, it was discovered that the needle used for access broke and perforated the lung, and the ¿pigtail¿ used to drain the fluid was stuck in the pulmonary artery.The patient was then transported to the operating room (or) for surgical intervention.The physician's opinion on the cause of this adverse event was procedure/patient condition related.Outcome of this adverse event was death.The patient required extended hospitalization as the complications due to the effusion required open heart surgery.Transseptal puncture was performed.

Manufacturer Narrative

On (b)(6) 2023, it was reported that the physician's opinion on the cause of death was complications from perforation and collapsed lung.Patient was stable the day after the perforation, passed two days after perforation due to complications.The needle that perforated the lung was the needle used for pericardiocentesis.The date of death was reported as (b)(6) 2023.Therefore, b 2.Date of death was updated.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18058275
• MDR Text Key: 327201767
• Report Number: 2029046-2023-02508
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• 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: ABBOTT SL0 NEEDLE; SMARTABLATE GENERATOR KIT-US; UNK CARTO 3
• Patient Outcome(s): Life Threatening; Hospitalization; Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female