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

Catalog Number SEE H10.

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fistula (1862); Sepsis (2067)

Event Date 03/06/2022

Event Type  Death  

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A 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.Note: catalog should be unk_smart touch bidirectional sf.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: (1) manufacture report number # 2029046-2023-00466 for product unk_smart touch bidirectional sf ; (2) importer report number # 2029046-2023-50007 product unk_smartablate generator.

Event Description

It was reported that a patient underwent a cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced sepsis, esophageal fistula and death.A family member of a patient reports the patient has died of septic shock due to atrial-esophageal fistula.The patient underwent cardiac ablation on (b)(6) 2022 which included use of a thermocool smarttouch ablation catheter.The procedure caused complications that resulted in the patient's death on (b)(6) 2022.Product identifiers are unknown.Reporter attempted to gather relevant data off the fda maude adverse event reports or through the patient's medical records.Reporter states the doctors and/or staff did not provide model number, serial number or any identifying numbers of the thermocool smarttouch that was used.Reporter states ¿it appears based on the lack of information from those two sources, the device may not have been reported by the hospital or doctors.However, the patient's cause of death was septic shock due to atrial-esophageal fistula, reported known complications of thermocool smarttouch sf bi-direct nav df.¿.

Manufacturer Narrative

On 2-mar-2023, additional information about the patient and event were received in patient medical records that were provided.It was reported the patient was admitted into a facility on (b)(6) 2022 with ultimate diagnosis of atrial esophageal fistula and cva.(b)(6) 2022 patient came to er due to gram positive cocci from blood cultures taken at a different facility 2 days prior.Patient had visited first facility due to fatigue, chills, low grade temp, decreased appetite since (b)(6) 2022 and weakness.Patient tested negative for covid and flu and was discharged home.Patient was then contacted at home regarding the blood culture results and patient then proceeded to er department of second facility.During er visit for 2nd facility, patient demonstrated worsening left upper extremity weakness and report of numbness.In the er, patient fell without headstrike while in the emergency room (er) after spouse lowered guard rail.Computed tomography (ct) scan revealed right parietal acute subarachnoid hemorrhage and patient was admitted for subacute sah, suspicion for infective endocarditis vs infected permanent pace maker (ppm) vs atrioesophageal fistula.Ct on chest (b)(6) 2022 gave no evidence of atrioesphageal fistula and records note that no oral contrast was utilized due to concerns of dysphagia after stroke.Patient¿s condition continued to deteriorate, and records indicate additional ct assessment with findings of new air emboli bilaterally increasing suspicion of atrioesophageal fistula.Education and consultation provided to patient's family and decision was made to forgo any further invasive treatments and categorize patient as do not resuscitate (dnr).Patient transferred to critical care unit (ccu) and progressed to death.Records note a office visits (b)(6) 2022 and (b)(6) 2022 s/p ablation but there is no information regarding these visits.Additional tests/lab data and medical history details have been added to sections b6.Tests/lab data including dates and b7.Medical history/preexisting condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 16482042
• MDR Text Key: 310646987
• Report Number: 2029046-2023-00466
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male