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

Catalog Number	D139501
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After an atrial fibrillation ablation with a qdot catheter, the patient left the ep (electrophysiology) room and experienced pericardial effusion treated with drainage and issue was resolved.After conducting an ablation, the patient left the room, and a pericardial effusion/cardiac tamponade was confirmed.Although the patient's condition was stable, drainage was performed, and the issue was showing signs of improvement/resolved.The physician's judgment on health hazard was non-serious (moderate/minor).No extended hospitalization noted.The physician's opinions on the relationship between the event and the product was that it was unknown whether carto 3 system and the products were involved in this adverse event.The cf (contact force) monitoring methods were dashboard, vector, and visitag.The visitag coloring settings was tag index, and the visitag additional filters used was fot (force over time).No abnormalities observed prior/during use of the products.Septal puncture was performed with rf (radiofrequency) needle.An ngen generator was used.The outcome of the adverse event was improved.The transseptal puncture was performed with rf (radiofrequency) needle.Prior to noting the pe/ct (pericardial effusion / cardiac tamponade) ablation was performed.No evidence of steam pop.The event occurred after the procedure was completed.The patient did not require cardiac surgery.The correct catheter settings were selected on the generator, and the ngen generator automatically selected correct catheter settings.No issues with flow rate change at the start of ablation, and ngen generator automatically controls appropriate irrigation flow according to the temperature.No error messages observed on biosense webster equipment during the procedure.
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 31578302l and no internal action related to the complaint was 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.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).
Additional Manufacturer Narrative
Additional information was received which indicated that transseptal puncture was performed with a radiofrequency (rf) needle.Therefore, the concomitant product section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• 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: 23103047
• Report Number: 2029046-2025-03227
• Device Sequence Number: 18079859
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: (01)10846835016710(11)250214(17)280213(10)31578302L
• 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,Followup
• Report Date (Section B): 10/21/2025

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: D139501
• Device Lot Number: 31578302L
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH, VIZ SMCURVE,SHORT.; 8.5F SHEATH, VIZ SMCURVE,SHORT.; CARTO 3 SYSTEM.; CARTO 3 SYSTEM.; NGEN GENERATOR.; NGEN GENERATOR.; OCTA,LNG,48P,3-3-3-3-3,D-CURVE.; OCTA,LNG,48P,3-3-3-3-3,D-CURVE.; RADIOFREQUENCY NEEDLE.; SOUNDSTAR ECO SMS 8F CATHETER.; SOUNDSTAR ECO SMS 8F CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown