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	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a cardiac ablation and the patient experienced cardiac tamponade that required drainage.Cavotricuspid isthmus (cti) ablation was performed using the qdot micro catheter and vizigo short.Brockenbrough (bb) was performed using the soundstar eco catheter.Pulmonary vein isolation (pvi) was performed using the varipulse catheter, and post-mapping of the left atrium (la) was performed using octaray.After completion of these procedures, the physician observed a decrease in blood pressure, confirmed using echocardiography, which revealed pericardial effusion.The patient's blood pressure recovered and stabilized after drainage, and the patient left the room.It was stated that the drained blood was venous blood, so the issue might have been related to ablation near the inferior vena cava (ivc), during cti ablation, or to coronary sinus (cs) catheter insertion.Visitag coloring setting was tag index.Visitag additional filter used was fot.Force visualization features were used were cf, realtime graph, vector, visitag.Parameters for stability were: range: 3mm, time: 3sec, fot: 25%5g, tag size: 2mm.Procedural activated clotting time was 350 seconds over.One catheter was used for each exchange.Transseptal puncture was performed, one site.There was no evidence of steam pop.Flow setting on the irrigated catheter was pre: 2 sec, post: 5 sec.There were no abnormalities observed prior to, nor during use of the product.
Additional 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.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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50091230
• Report Number: 3013300026-2026-02460
• Device Sequence Number: 10317509
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)260226(17)290225(10)31875114L
• 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: Foreign,Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 31875114L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 08/12/2026; 09/02/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/31/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2026
• 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: Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Race: Asian