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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
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 31928212l 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).
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction ablation procedure with a qdot micro catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.After the ablation, during hemostasis, st elevation occurred, and echocardiography revealed pericardial effusion.The patient recovered after drainage of the pericardial fluid.The patient has fully recovered.No error message observed on the biosense webster equipment during the procedure.Transseptal puncture was not performed.No ablations performed within the pulmonary veins.No evidence of a steam pop.The flow setting was set to pre:2sec, post: 0sec.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of the ablation.Physician¿s assessment of health hazard is non-serious (moderate/minor).There were no abnormalities observed during product use.The physician¿s opinion on the cause of this adverse event is that upon post-procedural review of the fluoroscopy images, the physician observed that cardiac motion appeared to worsen around the time of coronary sinus (cs) catheter insertion.Therefore, the physician believes that the event was more likely related to inadvertent contact or abrasion of the myocardial tissue during cs catheter insertion, rather than the event being attributable to the ablation.

• 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: 50941987
• Report Number: 3013300026-2026-03214
• Device Sequence Number: 10735158
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(17)290419(10)31928212L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 31928212L
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• 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: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Race: Asian