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

Catalog Number	D139505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31846689l 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.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a right sided atrial flutter ablation with a qdot micro and the patient experienced cardiac arrest that required medication and cardiopulmonary resuscitation (cpr), however, the patient died.It was reported that the patient had presented a month ago for pulse field ablation (pfa) ablation, however, the pfa case was not performed as the patient had a clot in the left atrial appendage at the time.The patient was brought back in for radiofrequency (rf) ablation, after being on 4 weeks on medication.A transesophageal echocardiogram (tee) was performed today, and no clot was observed in the patient.They believe the patient's ejection fraction (ef) was 55 a "few days earlier," and the patient's "ef" that day was 44.The physician obtained access, and advanced into the right atrium with the carto vizigo sheath and the qdot micro catheter to begin rf ablation along the cavotricuspid ishmus (cti) line.After about 2-3 minutes of ablation along the cti line with the qdot micro catheter, it was noticed that the patient blood pressure was dropping, even with an external pacer being utilized.The physician decided to take the patient off sedation, and it was then noticed that the patient's heart was beating, but there was no pulse.They believe the patient was not breathing at this point as well.Cpr was administered to the patient for 5 minutes, and an epinephrine drip was also provided to the patient.The patient's pulse was restored at this point, and the patient had left the room breathing on their own.10 minutes later, cpr had to be administered to the patient once again.Cpr was administered to the patient for about an hour, but the patient then passed away.The physician believes cardiomyopathy was the primary cause of death.

• Brand Name: QDOT MICRO
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 25641758
• Report Number: 3013300026-2026-02029
• Device Sequence Number: 15834242
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)260207(17)290206(10)31846689L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 31846689L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2026
• 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: Required Intervention; Death
• Patient Age: 89 YR
• Patient Sex: Male