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

Catalog Number	D139401
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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
During a clinical trial it was reported that a patient underwent a ventricular tachycardia procedure with a qdot micro catheter and an optrell mapping catheter with trueref technology and suffered a pericardial effusion which required prolonged hospitalization.Patient received an index ventricular tachycardia cardiac ablation on (b)(6) 2026.On (b)(6) 2026 start date and site awareness date of 06-feb-2026, the patient experienced pericardial effusion without hemodynamic relevance after the ablation procedure with a qdot micro catheter categorized as moderate and serious defined by in patient/prolonged hospitalization with an admission date of (b)(6) 2026 and discharged date of (b)(6) 2026.Relationship to study devices (qdot micro and optrell mapping catheter with trueref technology) was probable and not related to all other devices.The relationship with the index study procedure is causal and expected/anticipated.The outcome is resolved with an end date of (b)(6) 2026 with no intervention noted.The date the event is first reported to be an serious adverse event (sae) is 06-feb-2026.
Additional Manufacturer Narrative
Initially the adverse event was reported as mdr reportable under both the qdot micro catheter (manufacturer report number: 2029046-2026-00703) and an optrell mapping catheter with trueref technology (manufacturer report number: 2029046-2026-00713).However, during an internal review on 05-mar-2026, the event was reassessed as only mdr reportable under the qdot micro catheter as this device delivered the energy and was most likely the device associated with the adverse event.Therefore, the optrell mapping catheter with trueref technology was reassessed as not mdr reportable.The investigation was completed on 18-mar-2026.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 31777183l 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.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
• 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: 24508391
• Report Number: 2029046-2026-00703
• Device Sequence Number: 21317988
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)251001(17)280930(10)31777183L
• Combination Product (Y/N): N
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: D139401
• Device Lot Number: 31777183L
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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: IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD).
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 61 KG