MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

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

Patient Problems Stroke/CVA (1770); Fistula (1862); Inflammation (1932); Sepsis (2067); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no manufacture record evaluation (mre) review could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-03985 and 2029046-2019-03986 are related to this same incident.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent a persistent atrial fibrillation ablation procedure for pulmonary vein isolation with both the thermocool® smart touch® sf bi-directional navigation catheter and ep - shuttle rf generator system - 100w, and suffered pericarditis, cardiac tamponade, esophageal fistula (requiring surgical intervention), cerebrovascular accident and sepsis.Ten days post procedure, the patient was admitted to the hospital with symptoms of pericarditis.Echocardiogram was performed which was negative.Gastroscopy and esophagoscopy were performed and both were negative.Additionally, coronary angiogram was normal.Post procedure day 12, a cardiac tamponade was discovered, and a drain was placed in patient.Patient then had a cerebrovascular accident.Post procedure day 13, another gastroscopy was performed again.This time, the gastroscopy showed an esophageal fistula.Computed tomography and magnetic resonance confirmed this finding.Post procedure day 14, the patient had invasive surgery to close the esophageal defect and posterior left atrial wall.Post-surgery, the patient had sepsis and was then transferred to intensive care.Extended hospitalization was required due to the invasive surgery.Physician¿s opinion on the cause of the event is that it was procedure related.Transseptal puncture was performed with a heartspan needle and swartz sl0 sheath.There was no evidence of steam pop.Flow setting was set at 15ml, power of 35 w, and 8ml for less than or equal to 30w.Graph, dashboard, vector and visitag force visualization features were used during the procedure.Visitag parameters were stability 3mm, time 3 sec, force over time 25% 3 g, ablation index (ai) posterior 300-400, ai anterior 450-550, tag size 2mm, on posterior wall 25 watts and 30 watts were used, colored with ai.The tags were below 430 but, on some locations, (right inferior pulmonary vein posterior there was a force of 35 grams).The ablation was also quite extensive.There were no error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

Upon internal review on 6/19/2020, it was discovered that multiple fields in the initial report were mistakenly omitted from section a, including: patient age, age unit, and sex.Additionally, the brand name was incorrectly indicated and has been updated accordingly in section d1.Section h3 erroneously indicated "no" within the device evaluated by manufacturer(?).The proper selection is "not returned to manufacturer" all omitted or inaccurate fields have been updated within this supplemental report.Manufacturer's reference number:(b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9455540
• MDR Text Key: 182584636
• Report Number: 2029046-2019-03985
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; EP - SHUTTLE RF GENERATOR SYSTEM - 100W; HEARTSPAN® NEEDLE; SWARTZ SL0 SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR