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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	11/29/2025
Type of Reportable Event	Death
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).
Event or Problem Description
During a bwi-sponsored clinical study, it was reported that a patient underwent an atrial fibrillation ablation procedure with a qdot micro catheter and the next day they experienced cardiogenic shock that the medical team categorized as severe and serious.The patient's original procedure was on (b)(6) 2025 and their hospitalization lasted until their death on (b)(6) 2025.The relationship with study devices is not related.The relationship to the index study procedure is probable and expected/anticipated.The patient received medications consisting of amiodarone, atropine, and lidocaine.The patient underwent cardioversion, and surgery with ecmella.Leading to the patient's death, they experienced 11 days of no neurological improvement without sedation, hemodynamic deterioration, progressive multiple organ failure, multiple hemorrhagic events, and therapeutic options exhausted.
Additional Manufacturer Narrative
On 31-mar-2026, the product investigation was completed as the complaint device was not returned.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A device history record review was performed for the finished device 31644196l number, and no internal actions related to the complaint were found during the review.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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: 24164901
• Report Number: 2029046-2026-00307
• Device Sequence Number: 15770218
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: (01)10846835017045(11)250522(17)280521(10)31644196L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/22/2026

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: 31644196L
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown