MAUDE Adverse Event Report: Biosense Webster Inc QDOT MICRO; Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Catalog Number	D139504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Ventricular Fibrillation (2130)
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro catheter and a watchman appendage closure wherein the patient experienced cardiac arrest that required cardiopulmonary resuscitation (cpr), pacing and ecmo, ventricular fibrillation that required cardioversion, and hemorrhage.The patient expired.At the conclusion of atrial fibrillation ablation, during the process of extubating, patient developed bradycardia followed by hypotension.Soon after, loss of pulse was noted by anesthesiologist and cpr was started.X-ray showed that the right ventricle was not moving.No effusion was noted via trans-esophageal echocardiogram (tee).Pulse was noted after initial cpr for a short period.Transvenous pacemaker catheter was inserted.Patient developed ventricular fibrillation soon after and shocked to restore sinus rhythm was performed.Extracorporeal membrane oxygenation was inserted with normalization of blood pressure.However, abdominal distention was noted by echocardiogram that there was blood around the patient¿s liver.Decision was made to have a ct, results are unknown.Patient was placed in the intensive care unit where he passed away during early hours of the next morning (b)(6) 2026.The physician¿s opinion on the cause of this adverse event is that protamine was given too fast or in a large dose can cause severe anaphylactoid reactions, profound hypotension, pulmonary vasoconstriction, and cardiovascular collapse.
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 31875249l 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).

• 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50781131
• Report Number: 3013300026-2026-03030
• Device Sequence Number: 13209399
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741(17)290325(10)31875249L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: D139504
• Device Lot Number: 31875249L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2026
• 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; Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 173 LB