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

Catalog Number	D139505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/23/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (bilateral pvi and posterior wall isolation were performed) ablation with a qdot micro catheter and the patient experienced esophageal fistula that resulted in death.Fifteen days post procedure the patient had developed a left atrium esophageal fistula.At the time of the emergency call, the patient was conscious and made the emergency request independently.The chief complaints at the time of the call were chest pain and fever.By the time the ambulance arrived, the patient had developed impaired consciousness.Upon arrival at the hospital, the patient was able to speak; however, conversations were often incoherent.Right-sided paralysis was confirmed.A brain mri and whole-body ct were performed.The mri revealed scattered micro cerebral infarctions and the ct showed the presence of air in the trunk region (around the aorta).Given the history of atrial fibrillation ablation procedure, a left atrial¿esophageal fistula was strongly suspected.Emergency surgery was performed.Despite two days of hospitalization thereafter, the patient did not improve and died during admission.It was reported that the cause of death was hemorrhagic shock due to intra-abdominal bleeding with the liver suspected as the source of bleeding.The liver was potentially injured during the emergency surgery for left atrial¿esophageal fistula.The physician's opinion regarding the cause of the esophageal fistula was that it is considered procedure-related, as an esophageal temperature monitoring catheter was not used.No abnormal or unusual behavior was particularly observed compared to usual.Not device-related or patient-related.Intraoperatively, the esophageal course was marked using soundstar.No preoperative ct was performed.One catheter was used.Two transseptal puncture sites were performed during the procedure.The generator was set to temperature control mode.There was no device malfunction during the procedure.The carto® 3 system indicated to re-zero the catheter.Type of delivered energy was radio frequency (rf).Performed 117 ablations in the pulmonary veins.Bilateral pvi and posterior wall isolation were performed.The correct catheter settings selected on the generator.Target temperature: 50.Temperature cut off: 55, impedance cut off: min 50o, max 250o, delta 100o.Noted temperature: 39-41, impedance: min 111 o, max 144 o, power: 50 w.No issues with flow rate change at the start of ablation.No error messages observed on biosense webster equipment during the procedure.The physician commented that there was no causal relationship between the issue and the ep products.Qmode was used, with power output of 25 w.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31824134l and no internal actions related to the complaint were found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.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).

• Brand Name: QDOT MICRO
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25670686
• Report Number: 3013300026-2026-02084
• Device Sequence Number: 5596549
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(17)290204(10)31824134L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31824134L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian