MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number UNK_QDOT MICRO

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

Patient Problems Cardiac Arrest (1762); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 11/14/2023

Event Type  Death  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a ventricular tachycardia / premature ventricular complex ablation procedure using qdot catheter.The patient experienced cardiac arrest, coronary artery stenosis that required coronary angiogram with intra-arterial nitroglycerin, cpr and extra corporeal membrane oxygenation (ecmo).It was also reported that the patient had a "clot" in the left ventricle (lv).After first mapping and ablating with the qdot micro catheter in the right ventricular outflow tract (rvot), after multiple ablation attempts the physician accessed the left ventricular outflow tract (lvot) from a retrograde aortic approach.A new lvot map was created and four rf (radiofrequency) applications were made high in the lvot, near the aortic cusps.Mapping continued for thirty minutes for continuing premature ventricular contraction's (pvc), until a left bundle branch block (lbbb) was noticed on electrocardiogram (ekg), the patient's blood pressure dropped to 40's over 20's (40's systolic/20's diastolic).In addition, intracardiac echo (ice) revealed decreased lv movement.No pericardial effusion was present on ice.Cpr was initiated, a code was called ("code medications" were administered), multiple defibrillations were given for fine ventricular fibrillation, and an ecmo (extracorporeal membrane oxygenation) code team was called into the lab.The initial angiogram revealed closure of the left main coronary artery.Nitroglycerine was pushed directly into the left main artery and ecmo was started.The post-intervention angiogram revealed that the left main coronary artery was open.The patient's pressure stabilized on ecmo.At the time of the call the patient was in a viable rhythm, remained on ecmo, and they would soon be transferred to the icu.Based on interventional cardiologist comments, the cause of the event was uncertain, the left main had ostial narrowing, suggesting there may have been a coronary spasm or clot.Patient stabilized on ecmp but later expired in the icu.Secondhand information from staff stated that clot was found in the left ventricle (lv).Pt was anticoagulated.Activated clotting times (act) are performed at regular intervals.Act values are unavailable.There were no error messages on bwi product.The physician did not see any product problem.Generator parameters included qmode ablation at 50 w with default parameters.

• Brand Name: UNK_QDOT MICRO
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18304022
• MDR Text Key: 330190946
• Report Number: 2029046-2023-02907
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• 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: 12/11/2023

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: UNK_QDOT MICRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/11/2023
• 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; NGEN GENERATOR; NGEN PUMP
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Death
• Patient Age: 70 YR
• Patient Sex: Female