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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericarditis (4448)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A month after a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro catheter, the patient experienced pericarditis, and is under cardiology service.The report indicated that the patient came back with pericarditis one month after af ablation and is in intensive cardiology service.The patient did not experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing.Additional information was received indicating the physician¿s opinion on the cause of this adverse event was that it is a rare but occurring event due to ablation.The patient¿s outcome from the adverse event was reported as improved.The patient did not require cardiac surgery.The patient required extended hospitalization because the patient came back to hospital and needed extra hospitalization.The number of performed ablations was 140 with radiofrequency (rf) energy with qdot micro.The transseptal puncture was performed with boston needles, baylis.The flow settings were qmode and qmode+ and there were no issues with flow rate change at the start of the ablation.The force visualization features used were graph, dashboard, vector, and visitag.The visitag module parameters for stability used were range-5-30, time-3s, force over time (fot) - 5g, and size-3mm.No additional filter was used with the visitag.The color option used prospectively was other: index and joules.The correct catheter settings were selected on the ngen generator and there were no error reported or service done on the generator.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24144083
• Report Number: 2029046-2026-00278
• Device Sequence Number: 8997850
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: (01)10846835016741
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BOSTON NEEDLES, BAYLIS; CARTO 3 SYSTEM; NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown